Please see accompanying document: RFI _Venous-Thromboembolism

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1 University Hospital Lewisham Lewisham High Street London SE13 6LH Tel: Fax: Web: 31 July 2017 FOI Reference: RFI I am writing with regards to your request for information which was received by the Trust on 19 July Your request will now be dealt with under the Freedom of Information Act I now will respond to the request. Trust Merger Before I do this however, please note that with respect to the information we hold, Lewisham and Greenwich NHS Trust was formally created on 01 October 2013 following the merger of the Queen Elizabeth Hospital in Woolwich (QEH) from the decommissioned South London Healthcare NHS Trust with University Hospital Lewisham (UHL). This means that any data requested before October 2013 for QEH is unlikely to be held by the Trust. Where this applies, we will confirm this. Your Request I request that a copy of the following documents be provided to me: Trust Guidelines for Venous Thromboembolism (VTE) Prophylaxis in Surgical Patients. I would like you to include all surgical specialities at your trust, and specific guidelines you have for extended VTE prophylaxis in patients undergoing surgical procedures. Please see accompanying document: RFI _Venous-Thromboembolism In addition, I would like to know the approximate number of Colorectal resections performed at your trust during the period 01/1/2015 to 31/12/2015. Total for the Trust: 90 Re-use and Copyright One Trust serving our local communities

2 Please be aware that under the Re-Use of Public Sector Regulations 2015 the supply of this information is free to be used for your own use or for news reporting. Where this applies the source should be stated. For all other types of re-use e.g. publication or otherwise distributing information for public circulation, permission of the copyright owner will be necessary which may incur a charge. In most cases this will be the Trust. For documents, where copyright does not belong to the Trust the applicant will need to apply separately to the copyright holder for their terms and conditions. This is in accordance with the Copyright, Designs and Patents Act 1988 (CDPA). This will be highlighted where relevant. Breach of copyright law is an actionable offence and the Trust expressly reserves its rights and remedies available pursuant to the CDPA and common law. Further information on copyright is available at the following website: Internal Review If you unhappy with your response you can request a formal internal review. All requests must be provided in writing either via or to the postal address above. This should be done within two months of receipt of your response letter. All appeals must quote the original reference number and provide a reason for the appeal. Information Commissioner s Office Should you still remain unhappy with the outcome of your appeal you can write directly to the Information Commissioner s Office to ask for an independent review at the following address:- The Information Commissioner s Office Wycliffe House, Water Lane Wilmslow Cheshire, SK9 5AF Website: Helpline: In general, the ICO will only review cases where all internal review processes have been exhausted. I hope this answers your request. If you have any further queries about this matter then please do not hesitate to contact me. Yours sincerely One Trust serving our local communities

3 Venous Thromboembolism (VTE) Policy and Protocol:Thromboprophylaxis and Treatment Treatment and prophylaxis protocol for adults and children age of 16 and over (and younger children weighing 50 kg or more). If being read as a paper copy, please refer to Trust intranet to ensure this is the current version Document Reference: Version: 1.0 LGT/HAEM001 Date Effective: 03/03/2017 Author: Responsible Director: Consultation: Tullie Yeghen; Sara Stuart-Smith; Murugaiyan Thanigaikumar; Rebecca Murray; Julie Bridges Dr Elizabeth Aitken All Consultants and HONs, Director of Medical Education, Pharmacy Staff; IT and Information Department Staff Approved By and Date: Thrombosis Committee 27/01/2017 Medicines Management Committee 09/02/2017 Ratified By and Date: Quality and Safety Committee 03/03/2017 Target Audience: Equality Impact Assessment: All clinical staff looking after adults and children age 16 and over as well as younger children weighing 50 kg or more Neutral Review Date: 03/03/2018 Lewisham and Greenwich NHS Trust Page 1 of 25

4 Review and Amendment Log Version Date Author Type of change Summary of Change(s) January 2017 Tullie Yeghen; Sara Stuart- Smith; Murugaiyan Thanigaikumar; Rebecca Murray; Julie Bridges First LGT merged document This replaces the LHT document Venous Thromboembolism (VTE) Policy and Protocol version 1.1 dated 02 May 2013 and any historical SLHT documents Dissemination Plan Audience Method Paper or Electronic Responsible Staff Member Electronic Tullie Yeghen Consultants, HONs, General Managers Junior Doctors and regular inductions Electronic and teaching Mehool Patel, Tullie Yeghen, Sara Stuart- Smith Rebecca Murray Pharmacists , departmental meetings Electronic and face-to -face Ward Staff On-going reinforcement and adhoc Teaching Julie Bridges teaching Lewisham and Greenwich NHS Trust Page 2 of 25

5 Contents Section Heading Page Number 1 Introduction 4 2 Purpose and Scope 5 3 Definitions 5 4 Roles and Responsibilities Thromboprophylaxis Diagnosis and management of DVT and PE Training 21 7 Monitoring Compliance 22 8 References 24 9 Associated Documents 24 Appendices 1 Equality Impact Assessment 25 Lewisham and Greenwich NHS Trust Page 3 of 25

6 1.0 Introduction The House of Commons Health Committee for Prevention of Venous Thromboembolism (VTE) in Hospitalised Patients stated in its session that each year 25,000 people in the UK die from VTE. This figure includes patients admitted for medical care of serious illnesses, as well as those admitted for surgery. This is a larger number of deaths than are attributable to breast cancer, AIDS and road traffic accidents combined and 25 times the number of people who die as a result of MRSA infection. Litigation cases are said to be increasing whenever VTE occurs in the absence of demonstrable preventative measures. The definition of Hospital Acquired Thrombosis (HAT) should be noted in this context: HAT is a VTE episode occurring within 3 months of a hospital admission or intervention. Increased public and political pressure culminated in the publication of NICE Guidance 92 in January 2010 detailing measures aimed at preventing VTE in hospitalised patients. This notes that whereas lethal pulmonary embolus (PE) is the most feared complication of VTE disease, deep vein thrombosis (DVT) and non-fatal PE can lead to severe long-term morbidity in the form of post-thrombotic limb or pulmonary hypertension. NICE Guidance 92 recommends that each admitted patient should undergo a VTE assessment on admission, within 24 hours of admission and whenever the clinical situation changes, and receive appropriate thromboprophylaxis based on the balance between their thrombotic and bleeding risks, both of which are considered as part of the assessment. NHS Trusts are currently expected, as a minimum, to provide rolling data demonstrating that 95% or more of all admitted patients underwent a VTE assessment on admission. They are liable for a fine of 100 per patient below this target. Trusts are also expected to audit appropriate thromboprophylaxis regularly, and to undertake a Root Cause Analysis (RCA) for each case of HAT. The current Medical Director of the National Health Service is said to consider the reduction in VTE incidence since the implementation of these measures to be the greatest success of the NHS since his appointment in 2007, and an international achievement. This document is aimed at providing readily accessible and updated guidance on the prevention, diagnosis and treatment of VTE across Lewisham and Greenwich NHS Trust (LGT). This guidance applies to patients aged 16 or over, as well as to younger patients weighing more than 50 kg, noting however that Rivaroxaban/Direct Oral Anticoagulant (DOACs) are contraindicated in patients aged less than 18 as well as in pregnant or breast feeding women. It should be read in conjunction with the following guidance: LGT s Enoxaparin/Unfractionated heparin guidelines South London Area Prescribing Committee s DOAC Initiation and Transfer of Care documentation LGT s Maternity VTE guidelines Lewisham and Greenwich NHS Trust Page 4 of 25

7 LGT s Thromboprophylaxis Guidelines for Ambulatory patients with Achilles tendon rupture or requiring Immobilisation (including Plaster Cast) for Lower Limb Injury, LGT s Emergency Department (ED) Integrated Care Pathways for Deep Vein Thrombosis (DVT) and for Pulmonary Embolus (PE) LGT s Anticoagulation Clinic Guideline. All VTE assessments must be performed on the icare system whenever possible, so as to enable electronic statistical analysis for the mandatory data returns. If a VTE assessment is performed on the patient s drug chart, this fact must be recorded on icare, or an assessment performed on icare as well, within 6 hours of admission. 2.0 Purpose and Scope This policy sets out how the Trust aims to guide and improve the prevention, diagnosis and management of Venous Thromboembolic disease (VTE) in accordance with national (including NICE) guidance, and to outline the education and monitoring requirements / processes. It applies to: All Trust medical, nursing, midwifery and pharmacist staff whether permanent, temporary, on honorary contracts, and working in all settings. 3.0 Definitions AES: Anti Embolism Stocking CDU: Clinical Decision Unit CTPA: CT pulmonary Angiogram DVT: Deep Vein Thrombosis DOAC: Direct Oral Anticoagulant Agent ED: Emergency Department HAT: Hospital Acquired Thrombosis HON: Head of Nursing IPC: Intermittent Pneumatic Compression Device LGT: Lewisham and Greenwich NHS Trust PE: Pulmonary embolus PESI: Pulmonary Embolus Severity Index RCA: Root Cause Analysis TED: Thromboembolic Disease VQ SPECT: Highly sensitive low dose three dimensional low dose ventilation perfusion scan VTE: Venous thromboembolism (DVT or PE) 4.0 Roles and Responsibilities Clinical staff should ensure adherence to this policy whenever possible, bearing in mind that it is unlikely to include all clinical scenarios. If in doubt, the case should be Lewisham and Greenwich NHS Trust Page 5 of 25

8 discussed with the consultant in charge of the patient and with the Haematology team if further advice is needed. Decisions should be carefully documented in the patients notes, with reasons supporting the course of action, particularly in the case of deviation from this policy and the procedures herein. 4.1 Thrombosis Committee ensures: The monitoring of the effectiveness of this policy (see section 13.0) Reporting to its parent committee (Patient Safety Committee) on effectiveness and any exceptions. 4.2 Divisional and Clinical Directors ensure: The implementation of this policy within their clinical areas Providing resources to ensure that staff are trained and updated to ensure compliance with this policy. 4.3 Director of Medical Education ensures that: Education on VTE is incorporated in to the education programme for all medical staff in training. 4.4 Labour Ward Lead Obstetrician ensures that: This policy is applied within Maternity Services The lead consultant haematologist is informed promptly of any changes advised by the Royal College of Obstetricians and Gynaecologists. 4.5 Consultant Haematologist Lead for VTE chairs the Thrombosis Committee and ensures that: This policy and protocol is monitored by the Thrombosis Committee. Reports on effectiveness are made to the Patient Safety Committee annually, and exception reports as required This policy is reviewed and updated within 3 years of publication or when national guidance is changed 4.6 Individual medical, nursing and midwifery staff ensure: They understand and implement the protocols contained in this policy Maintain their own awareness of VTE, the risk to patients, and how to make them aware of those risks and what to do if they suspect VTE Lewisham and Greenwich NHS Trust Page 6 of 25

9 5.0 Prevention, diagnosis and treatment of VTE 5.1 General Preventative Measures All patients should receive the Trust VTE Information Leaflet (Thrombosis Research Institute leaflet at time of approval of policy) on admission, or, in the case of elective admissions, at Surgical Pre-assessment, and reinforcement of the contents of the leaflet given verbally. All patients must be encouraged to mobilise as soon as their clinical condition permits. Dehydration and infection must be treated promptly. Patients admitted routinely for surgical procedures should, if agreeable after appropriate discussion, stop the combined OCP and HRT 4 weeks prior to the procedure and, whenever possible, avoid continuous travel for more than 3 hours for 4 weeks before, and 4 weeks after the procedure. Patients whose contraception has been discontinued MUST be offered alternative contraceptive advice. Patients remaining on oestrogen containing hormonal treatments or unable to avoid continuous travel peri-operatively should be considered at risk of VTE and be offered appropriate thromboprophylaxis. Regional anaesthesia should be considered in suitable cases as it presents a lower risk of VTE than general anaesthesia. On discharge, patients must be made aware verbally that if they develop symptoms suggestive of DVT (painful, swollen or red limb) or PE (chest pain, shortness of breath, haemoptysis or collapse) within 3 months of admission, they should present to the Emergency Department (ED) urgently. They should also be given a copy of You and your Medicines leaflet, which re-iterates this information. Patients discharged on mechanical or pharmacological thromboprophylaxis should be given verbal and written information about their treatment, including duration, and whom to contact in the case of queries or untoward effects. 5.2 VTE Risk Assessments for In-patients Please note that the thrombosis risk criteria are very different for women who are pregnant or within six week of delivery from those in the general patient population. Pregnant or puerperal women therefore require a specific VTE risk assessment tailored to their condition. Please see the Maternity VTE policy for Women who are Pregnant or within 6 Weeks of Giving Birth on Trust Intranet. The main differences between the standard VTE risk criteria and the pregnancy / puerperium criteria are broadly as follows: 1. Pregnant women admitted for medical reasons require a full risk assessment irrespective of mobility and should be considered at increased risk of VTE. 2. All surgery presents a thrombotic risk in pregnancy irrespective of site and duration. 3. There are specific pregnancy related thrombosis risk factors including age greater than 35, ovarian hyperstimulation, hyperemesis gravidarum, multiple pregnancies, pre-eclampsia. 4. Blood loss or blood transfusion are thrombosis risk factors in pregnant / puerperal women. Lewisham and Greenwich NHS Trust Page 7 of 25

10 5. All pregnant women require a VTE assessment at booking, and at delivery as a minimum. 5.3 On Admission A VTE risk assessment (see icare or Trust adult drug chart for general risk assessment, icare and Maternity VTE Policy for specific risk assessment in pregnancy and the puerperium) must be completed on admission for all patients, again at 24 hours and whenever their clinical situation changes. Day cases and Clinical Decision Unit (CDU) patients also require VTE risk assessments, which are usually performed by the admitting doctor. The VTE risk assessment forms part of the clinical record. In the Division of Surgery, patients are not called to theatre without a completed VTE assessment. It should be noted that risk factors pertaining to the total duration of surgical plus anaesthetic time will only be confirmed at the end of surgery. 5.4 Automatic low Risk Patients The following groups of patients however are considered to be at very low risk of VTE from the point of view of their admission, and do not require individual risk assessments or chemical thromboprophylaxis unless prescribed previously/already. 1. Patients attending as day cases for endoscopic procedures, including hysteroscopy and colposcopy, under conscious sedation/ local anaesthetic. 2. Patients attending as day cases for skin biopsies or removal of skin lesions under local anaesthetic. 3. Patients attending the Haematology / Chemotherapy day Units for cytotoxics, otherwise these areas or the Ambulatory Care Units for procedures under local anaesthetic (bone marrow biopsy, etc) or blood transfusion/ infusion therapies. 4. Patients with bleeding disorders attending the Haemophilia Centre. 5. Pregnant patients attending the Obstetrics Day Unit for examination, and not requiring admission. 6. Patients attending the Pain Clinic for minor procedures under local anaesthetic. 7. Other minor procedures under local anaesthetic 8. Ambulatory day patients attending for dialysis. 5.5 Documenting the VTE Risk Assessment In order for the Trust to record the percentage of eligible admissions that undergo a VTE risk assessment as per national requirements, the fact that the risk assessment has been completed must be recorded electronically. This is achieved preferably by performing the assessment direct on icare, otherwise by recording on icare the fact that the assessment was performed on paper. All surgical and obstetric/puerperal patients require a full VTE risk assessment on admission unless in one of the categories above, and irrespective of mobility. Medical patients however, if assessed as not expected to have significantly reduced mobility relative to their normal state do not require further risk assessment. The Lewisham and Greenwich NHS Trust Page 8 of 25

11 appropriate box on icare or prescription chart should be ticked, signed and dated at this stage. Caution should be exercised in the case of medical patients with pre-existing poor mobility who are admitted acutely, for whom the local recommendation is to carry out a full risk assessment and give thromboprophylaxis unless contraindicated. The next step is to assess and document the patient for thrombotic, then for haemorrhagic risk by answering yes or no in the relevant boxes on the form/eform before reaching and documenting a decision as to whether thromboprophylaxis is required, and if so which type. The form should then be signed and dated, and the name of the person completing it printed if on paper, or ticked as verified if performed electronically. Once a decision has been reached, the appropriate treatment should be prescribed. In the case of patients who are not pregnant or within six weeks of delivery, thrombosis risk factors are listed below.. Please see the Maternity VTE policy for Women who are Pregnant or within 6 Weeks of Giving Birth on Trust Intranet. 5.6 Risk Factors Patient related thrombosis risk factors: 1. Active cancer or cancer treatment 2. Age>60 years 3. Known thrombophilias (deficiencies in Protein C, Protein S or Antithrombin, Factor V Leiden, Prothrombin gene mutation, lupus anticoagulant, antiphospholipid syndrome, Behcet s disease, PNH and homocystinaemia as well as high levels of coagulation factors). Seek specialist Haematology advice on how to manage these patients. 4. Obesity with BMI>30kg/m 2 5. One or more significant medical co-morbidities, eg heart disease, sickle cell disease, metabolic, endocrine or respiratory pathologies, acute infectious diseases, inflammatory conditions, etc. 6. Personal history or first degree relative with history of VTE 7. Use of hormone replacement therapy or of oestrogen containing contraceptive therapy. 8. Varicose veins with phlebitis Procedure related thrombosis risk factors: 1. Significantly reduced mobility for 3 days or more 2. Hip or knee replacement 3. Hip fracture 4. Total anaesthetic plus surgical time >90 minutes 5. Surgery involving the pelvis or lower limb with total anaesthetic plus surgical time>60 minutes 6. Acute surgical admission with inflammatory or intra-abdominal condition 7. Critical care admission 8. Surgery with significant reduction in mobility Lewisham and Greenwich NHS Trust Page 9 of 25

12 Next, the patient should be assessed for bleeding risks, which are listed below: Patient related bleeding risk factors: 1. Active bleeding 2. Acquired bleeding disorders (such as acute liver failure) 3. Concurrent use of anticoagulants known to increase the risk of bleeding (such as warfarin with INR>2) 4. Acute stroke 5. Thrombocytopaenia (platelets<75 x10 9 /l) 6. Uncontrolled systolic hypertension (230/120 mmhg or higher) 7. Untreated inherited bleeding disorders such as haemophilia and von Willebrand s disease) Admission related bleeding risk factors: 1. Neurosurgery, spinal surgery or eye surgery 2. Other procedure with high risk of bleeding 3. Lumbar puncture/epidural/spinal anaesthesia expected within the next 12 hours 4. Lumbar puncture/epidural/spinal anaesthesia in the last 4 hours. Any yes answer to the thrombosis risk factor questions would dictate the use of chemical thromboprophylaxis (Enoxaparin [Clexane ] or unfractionated heparin in the majority of cases, Rivaroxaban in the case of elective total hip and total knee replacement) unless there are one or more yes answers in the bleeding risk categories. See separate Enoxaparin and Unfractionated Heparin Guideline on Trust intranet, and Summary of Product Characteristics for Rivaroxaban, noting the effects of weight and renal function on the dosage of DOACs, enoxaparin and unfractionated heparin. Patient with weight >100kg should receive 5000 units of unfractionated heparin subcutaneously 3 times a day if unable to receive enoxaparin. The recommended dose for patients below 100kg is 5000 units subcutaneously twice daily. Patients with both thrombosis and bleeding risks should be discussed with the Consultant or ST3+ in charge of the patient, who will ascertain which risk is greater, and make the appropriate decision. The Haematology team should be involved in the management of all patients with haematological disorders, and in other cases if further advice is required on the risk /benefit balance of thromboprophylaxis. It should be noted that anti-platelet drugs including aspirin, dipyridamole, ticagrelor, prasgurel and clopidrogrel as well as combinations of these drugs are not considered to be adequate thromboprophylactic measures in patients at risk of thrombosis, and that patients receiving them should undergo a risk assessment and receive thromboprophylaxis, including pharmacological, if the risks of thrombosis outweigh the haemorrhagic risks. In terms of bleeding risks, clopidrogrel is generally stopped 7 days before surgery, but a risk /benefit assessment of stopping anti-platelets drugs should always be performed beforehand, with involvement of the patient s Cardiologist if necessary and noting that the discontinuation of clopidogrel, ticagrelor or prasugrel is potentially hazardous in patients with recent coronary artery stents. Lewisham and Greenwich NHS Trust Page 10 of 25

13 5.7 Which Out-Patients should be considered for thromboprophylaxis? All pregnant women should undergo a pregnancy specific outpatients VTE risk assessment at booking, and a decision made as to whether they require ambulatory thromboprophylaxis throughout the pregnancy based on this. It will be noted that a combination of risk factors (unless the risk factor is previous VTE or known thrombophilia - either of which alone requires thromboprophylaxis) is usually required to warrant thromboprophylaxis in a pregnant Out-patient when one is enough in the in-patient context. Myeloma patients requiring thalidomide or lenalidomide will usually require thromboprophylaxis with Enoxaparin, as these drugs are highly thrombogenic. Although none of the following categories of patients should be offered thromboprophylaxis routinely in the out-patients context, consideration should be given as to whether they should receive thromboprophylaxis based on a risk assessment: patients in plaster casts or with Achilles Tendon Rupture (see separate Guideline) patients with in-dwelling venous catheters, and patients with cancer. Careful attention should be paid to other risk factors for thrombosis, particularly reduced mobility, in all these patients, and appropriate action taken. In the case of a plaster cast, pharmacological thromboprophylaxis, if used, should be continued until the plaster has been removed. 5.8 Which thromboprophylaxis, when to start, and when to stop? Thromboprophylaxis, if indicated, should be started on arrival at the hospital (if necessary by prescribing a stat dose ) in the case of emergency admissions unless a surgical procedure or other invasive procedure is to take place within 12 hours. Thomboprophylaxis is can be subdivided into mechanical and pharmacological: Mechanical methods: 1. TED / anti-embolism stockings (AES) are the commonest. See paragraph 7 below for safe use. 2. Intermittent pneumatic compression devices (IPCs) 3. Foot impulse devices Mechanical methods should be started on arrival at the hospital (see section 8 on the correct use of TED / AES stockings) and continued until the patient is fully mobile. Intermittent pneumatic compression devices are favoured over TED / AES stockings in patients undergoing total hip or total knee replacement, as they are prone to leg oedema which may make TED / AES stockings unsuitable in the immediate postoperative period. Lewisham and Greenwich NHS Trust Page 11 of 25

14 Pharmacological methods (only main methods in use in the Trust listed): 1. Enoxaparin (Clexane), usually 40 mg. See separate Enoxaparin guidelines for use in extremes of weight and renal impairment*, for Heparin Induced Thrombocytopenia (HIT) monitoring** and for guidance on timing for use around epidural, spinal and regional anaesthesia***. * The prophylactic dose of enoxaparin used in patients weighing more than 100kg is increased to 40mg bd, and to 60mg bd for patients weighing more than 150 kg. For patients weighing less than 50 kg, the 20mg s/c daily prophylactic dose should be used. These doses are halved for patients with creatinine clearance <30 ml/min or unfractionated heparin used 5000 units bd increased to tds for patients weighing >100kg ** Most patients on low molecular weight heparins do not require HIT screening. Patients requiring HIT screening are all those on unfractionated heparin and those on low molecular weight heparin who are either post-operative or post cardiopulmonary bypass and have received any heparin within 100 days. The FBC should then be monitored for heparin induced thrombocytopenia (HIT) at 24 hours from start if heparin received within 100 days, otherwise from day 4, then on alternate days for in-patients, and at least twice weekly on out-patients for the first 14 days. A platelet reduction of 30% or more below baseline or to below the normal range should prompt immediate discussion with the Haematology team. *** Wait at least 12 hours post standard prophylactic dose of enoxaparin 20 mg or 40 mg before lumbar puncture or neuraxial analgesia/anaesthesia. Wait 4 hours before administering a standard prophylactic dose of Enoxaparin 20 mg or 40 mg maximum with epidural in situ and 12 hours after a standard prophylactic dose of Enoxaparin before removing the epidural, and then delay any further injection for at least 4 hours. Do not use higher doses of enoxaparin with epidural in situ. Epidural insertion or removal should be delayed by 24 hours following higher doses of enoxaparin. Consider doubling these times in patients with renal impairment. Lewisham and Greenwich NHS Trust Page 12 of 25

15 Note that unfractionated heparin should be considered instead in patients with renal impairment and creatinine clearance<30ml/min. Also note that patients need to be weighed and their renal function, clotting and FBC assessed before treatment. 2. Unfractionated heparin 5000 units bd (tds if weight >100kg) is the prophylaxis of choice for patients on renal replacement therapy. It should be considered in patients with renal impairment and creatinine clearance<30ml/min particularly if prophylaxis is to last more than a week or if renal function is deteriorating. Dose adjusted Enoxaparin is acceptable provided the patient is not on renal replacement therapy. HIT monitoring is always required for patients on unfractionated heparin, and epidural guidance as for Enoxaparin. 3. Rivaroxaban 10 mg once a day (see Summary of Product Characteristics) in elective total hip and knee replacement surgery only in patients with creatinine clearance 30mls/min or more. Rivaroxaban is contraindicated in patients with severe renal impairment, in whom unfractionated heparin or dose adjusted enoxaparin should be used. The Trust also uses Enoxaparin in patients in whom Rivaroxaban is indicated until the removal of an epidural. Rivaroxaban should not be administered for 24 hours or more from the last dose of Enoxaparin and 6 hours or more from the removal of the epidural, whichever is later. 4. Consult Haematology team for patients who require pharmacological thromboprophylaxis but have previously suffered from HIT. These patients will need alternative agents such as Fondaparinux or Danaparoid unless suitable for Rivaroxaban. CAUTION It should be noted that heparins are of animal origin, which may make them unsuitable for certain patients due to personal beliefs. Alternative agents should be offered in such cases on the advice of the Haematology team. In exceptional cases, a temporary inferior vena cava (IVC) filter may be considered in patients who are at very high risk of VTE (for example previous VTE event or active malignancy) in whom all other mechanical and pharmacological prophylactic methods are contra-indicated. It should be noted that there are no facilities in the Trust for inserting or removing temporary IVC filters. These procedures are usually carried out at St Thomas Hospital Interventional Radiology department, who will also advise on the latest possible date of filter removal (usually 3 months maximum) after which the filter will become permanently embedded in the vena cava. Medical Patients Medical patients assessed as requiring thromboprophylaxis will receive a pharmacological agent only unless at excessive risk of bleeding, when a mechanical device (usually TED / AES stockings) should be substituted. Medical patients at increased risk of thrombosis who are unsuitable for both pharmacological agents and TED stockings (e.g. patients with recent stroke) should be offered an alternative mechanical method such as intermittent mechanical compression or foot impulse device, noting also that allergies to the materials in these devices may occur or be already present. Thromboprophylaxis, if required, should be started on arrival at the hospital in the absence of temporary contraindication (e.g procedure planned in next 12 hours) and continued until discharge in the absence of new contraindications. Lewisham and Greenwich NHS Trust Page 13 of 25

16 Stroke Patients Patients with acute stroke should not routinely be offered chemical thromboprophylaxis in the acute stage. If a patient with stroke is at high risk of VTE they should be provided with intermittent pneumatic compression, which is available on the Stoke Unit. Patients with stroke should not receive TED stockings as prophylaxis but should be offered an intermittent compression device instead. Any prophylaxis prescribed should be administered until the acute event is over. Palliative Care Patients In palliative care patients and those on end of life pathways, thromboprophylaxis should not be given routinely but should be discussed with the patient and family with a risk benefit assessment. Surgical and Obstetric Patients Surgical and Obstetric patients at risk of thrombosis should be offered both a mechanical and a pharmacological thromboprophylactic method if considered at risk of thrombosis with no bleeding risk or other contraindication. Rivaroxaban or other DOAC thromboprophylaxis is only recommended for patients undergoing elective total knee replacement (recommended duration 2 weeks) and elective total hip replacement (recommended duration 5 weeks). Rivaroxaban should start 6-10 hours post operatively. See also paragraph 2 page 9 above for renal function and epidural requirements, and Rivaroxaban guidance for pre-treatment blood tests and drug interactions. It is of note that 6 weeks of postoperative thromboprophylaxis is recommended for those patients requiring Enoxaparin or unfractionated heparin after total hip replacement. The British National Formulary recommends that Enoxaparin should be started the night before the procedure, and given 24 hourly thereafter. In practice, pre-operative Enoxaparin is only given in patients at very high risk of thrombosis (for example patients undergoing surgery for colo-rectal cancer and patients with previous DVT but no longer on anticoagulants undergoing surgery). Twelve hours at least should elapse between the last prophylactic dose of Enoxaparin and surgery/procedure. The first dose of Enoxaparin is generally given 6-12 hours post operatively provided there is no bleeding, then every 24 hours until the patient is fully mobile. This is 5-7 days in most types of abdominal, urological, gynaecological, vascular and ENT surgery. Patients undergoing prolonged abdominal surgery for cancer should receive thromboprophylaxis for 28 days. Lewisham and Greenwich NHS Trust Page 14 of 25

17 Trauma patients Trauma patients, particularly if involving the lower limbs or pelvis, should start mechanical and pharmacological thromboprophylaxis on arrival at the hospital provided that there are no contra-indications. This is irrespective of the date on any surgical procedures that are planned, provided the pharmacological agent is stopped 12 hours before surgery. The thromboprophylaxis should be continued until the patient is mobile, and, in the case of a fractured neck of femur, for minimum of six weeks. Day Surgery patients A normally mobile patient with no risk factors will not need any thromboprophylaxis. For day surgical patients in whom thromboprophylaxis is indicated, TED stockings should be applied pre-theatre unless contra-indicated. Thromboprophyaxis should be continued until the patient is fully mobile, so if they are fully mobile on discharge, they may need no further thromboprophykaxis. 5.9 Do s and Don ts with TED / AES stockings TED stockings should be prescribed on the patient s prescription chart, and signed by nursing staff on a daily basis to indicate that they are in situ and the patient s leg has been checked. Do NOT offer TED / AES (anti-embolism) stockings to patients who have: 1. Suspected or proven peripheral arterial disease 2. Peripheral arterial bypass grafting 3. Peripheral neuropathy or other causes or sensory impairment 4. Any local conditions in which stockings may cause damage e.g. fragile tissue paper skin, dermatitis, gangrene or recent skin graft 5. Known allergy to material of manufacture 6. Cardiac failure 7. Severe leg oedema or pulmonary oedema from congestive heart failure 8. Unusual leg size or shape 9. Major limb deformity preventing correct fit 10. Stroke Use caution and clinical judgement when applying TED / AES stockings over venous ulcers. 1. Ensure that patients who need anti-embolism stockings have their legs measured and that the correct size of stocking is provided. Stockings should be fitted and patients shown how to use them by staff trained in their use. 2. Both knee length and thigh length stockings are suitable, although knee length stockings are easier to use and may therefore be preferable. 3. Ensure that patients who develop oedema or postoperative swelling have their legs re-measured and stockings refitted. 4. If arterial disease is suspected, detect pedal pulses and seek expert opinion before fitting anti-embolism stockings. 5. TED stockings should provide graduated compression and produce a calf pressure of 14-15mmHg. 6. Encourage patients to wear their stockings day and night until they no longer have significantly reduced mobility. Lewisham and Greenwich NHS Trust Page 15 of 25

18 7. Remove stockings daily for hygiene purposes and to inspect skin condition. In patients with a significant reduction in mobility, poor skin integrity or any sensory loss, skin should be inspected two or three times per day, particularly the heels and bony prominences. 8. Discontinue the use of stockings if there is marking, blistering or discolouration of the skin, particularly over the heels and bony prominences or the patient experiences pain or discomfort. If suitable offer a foot impulse device or intermittent pneumatic compression device as an alternative. 9. Show patients how to use stockings correctly and ensure they understand that this will reduce their risk of developing VTE. 10. Monitor the use of stockings and offer assistance if they are not being worn correctly Symptoms and Signs of DVT and PE Deep vein thrombosis (DVT) generally presents with pain and/or swelling of the affected limb, which can also appear erythematous. DVTs associated with medical care typically present 7 days after the care episode. Many DVTs are clinically silent, and their first manifestation may be when the patient presents with symptoms and signs of pulmonary embolism (PE), which include pleuritic chest pain, shortness of breath, haemoptysis, and dry cough. Associated clinical signs include hypoxia, tachycardia, hypotension and a pleural rub, but can also be absent. PEs associated with medical care typically present 21 days after the care episode. If the PE is massive, the patient may present with crushing central chest pain similar to myocardial infarction, cardiovascular collapse, or cardiac arrest (pulseless electrical activity, PEA). In such cases, both the troponin and the brain natriuretic peptide assays (BNP) may be elevated Diagnosis and Treatment of DVT Patients with DVT are usually diagnosed and treated as out-patients with Rivaroxaban unless contraindicated according to an established Integrated Care Pathway (ICP) for out-patients with DVT which is available for use initially in the Emergency Department, then at the DVT clinic on the Ambulatory Care Unit in University Hospital Lewisham and the Clinical Decision Unit at the Queen Elizabeth Hospital. Other DOACS are also available for use in LGT. The ICP is based on a Wells score, D-Dimer then Doppler or Vascular Laboratory scan if DVT still suspected. Thrombosis of a superficial vein occurring within 3cm of a junction with a deep vein or deep perforator is treated as DVT. Other risk factors not covered in the Wells score should also be considered when assessing a patient, eg BMI>30, IVDU, family history of VTE, known thrombophilia, combined oral contraceptive pill or HRT, varicose veins with thrombophlebitis. The principles of the ICP are applicable to patients having to be admitted due to ill health or poor comprehension/compliance precluding their treatment as out-patients. See separate protocols for pregnant and puerperal women, noting in particular that they are unsuitable for Rivaroxaban or other DOACs and that the dose of Enoxaparin is different for pregnant patients at 1mg/kg twice daily based on pre-pregnancy or early pregnancy weight. Lewisham and Greenwich NHS Trust Page 16 of 25

19 Patients with large proximal DVTs causing circulatory impairment should be considered for urgent localised thrombolysis, which is not performed in the Trust. These patients should be discussed with the vascular surgeons and interventional Radiologists at Guys and St Thomas NHS Trust with a view to transfer. Patients with a provoked DVT and reversible risk factors require 3 months of anticoagulation only provided their symptoms have resolved. These patients, if managed with Rivaroxaban, can be managed by the medical team alone and do not require an anticoagulant clinic (QEH) or thrombosis clinic (UHL) referral. Patients requiring longer courses of Rivaroxaban should be referred to these clinics with the aim that they would be seen after 2 months of treatment so as to give the General practitioner a month s notice of transfer of care at 3 months, using documentation on Trust Intranet. The Trust is required to provide the first 3 months of medication for all patients initiated on a DOAC before prescribing is transferred to the GP for those requiring longer treatment. A DOAC VTE initiation proforma, available on the intranet, must be completed and sent to the GP. All patients stated on anticoagulants must be given appropriate counselling and a yellow anticoagulant alert card, as well information specific to the specific anticoagulant they will be using. Patients with confirmed unprovoked DVT must have a detailed physical examination including rectal and vaginal examinations to exclude underlying cancer, and undergo, as a minimum, CXR, uranalysis and, in the case of men, PSA. A CT or ultrasound examination of the abdomen and pelvis should also be considered together with mammograms. Anti-cardiolipin antibodies should also be checked. Patients with unprovoked DVT should be considered for life long anticoagulation. Whilst awaiting confirmation of the DVT, the patient -can be started on Rivaroxaban 15 mg bd. If DVT confirmed, this should continue for 3 weeks after which 20 mg daily should be started (or 15 mg if renal impairment present and risk of bleeding outweighs risk of recurrent thrombosis) provided there are no contraindications and the initiation form is completed. See ICP and DOAC initiation documentation on Intranet, noting in particular the need to weigh patient accurately and check their renal function (including renal function according to Cockroft-Gault calculation) prior to the start of treatment. The patient will also need to undergo a baseline FBC and clotting screen, and any abnormalities discussed with the Haematology team unless trivial or easily explained otherwise. Patients with weight over 120 kg or less than 46 kg are not recommended for Rivaroxaban unless specifically initiated and supervised by a Consultant Haematologist and should receive Enoxaparin instead. Patients unsuitable for Rivaroxaban can usually be treated with Enoxaparin (see Intranet for Enoxaparin and Unfractionated Heparin Dosing and Administration Guideline), and should remain on Enoxaparin if their DVT was cancer related. There is currently a site preference for QEH patients to be started on Enoxaparin pending DVT confirmation, after which a switch to Ribaroxaban is operated if the DVT is confirmed. Other patients unsuitable for Rivaroxaban who do not require long term enoxaparin therapy should, after appropriate counselling/written information and in the absence of contraindication, be started on a suitable warfarin loading regimen, noting that the Fenharty (10mg, 10mg, 5mg) regimen requires daily INR checks during induction and is not suitable for elderly/frail patients or those with abnormal baseline INR. The Lewisham and Greenwich NHS Trust Page 17 of 25

20 patient should also be referred to the anticoagulant clinic. The Enoxaparin is usually stopped when the INR reaches 2 or above, but may be continued until an INR of 3 if the patient requires a higher INR range. See also Anticoagulant prescription section of Drug Chart, Anticoagulant Clinic referral form, Anticoagulant Clinic SOP and Protocol for safe Discharge of patients on warfarin for further information. A thrombophilia screen will be required in patients under the age of 50 with unprovoked DVT if there are plans to discontinue anticoagulation, and will be arranged by the Anticoagulant clinic after the patient has completed an appropriate period of anticoagulation Diagnosis and Management of PE Patients with suspected PE are investigated according to modified Well s score, D- Dimer and CTPA (CT Pulmonary Angiogram) or VQ SPEC, according to algorithm in section 5.13 below, while the severity of their condition is assessed according to PESI score (Pulmonary Embolus Severity Index, also in section 5.13) to ascertain suitability for treatment in the ambulatory care setting. Other risk factors not covered in the Wells score should also be considered when assessing a patient eg BMI>30, IVDU, family history of VTE, known thrombophilia, combined oral contraceptive pill or HRT, varicose veins with thrombophlebitis. First line treatment is with Rivaroxaban unless contraindicated, according to DOAC initiation documentation and checklist on Trust Intranet. See separate protocols for pregnant and puerperal women, noting in particular that they are unsuitable for Rivaroxaban or other DOACs and that the dose of Enoxaparin is different for pregnant patients at 1mg/kg bd based on pre-pregnancy or early pregnancy weight. Patients with a provoked PE and reversible risk factors require 3 months of anticoagulation only provided their symptoms have resolved and their PESI score is I or II. These patients, if managed with Rivaroxaban, can be managed by the medical team alone and do not require an anticoagulant clinic (QEH) or thrombosis clinic (UHL) referral. Patients requiring longer courses of Rivaroxaban should be referred at these clinics with the aim that they would be seen after 2 months of treatment so as to give the General practitioner a month s notice of transfer of care at 3 months, using documentation on Trust Intranet. As mentioned for DVT treatment above, the Trust has to supply the first 3 months of medication before the patient s GP will take over prescribing, and a DOAC initiation proforma must be completed and sent to GP. Patients with PESI score II, IV or V (irrespective of whether PE provoked or not) should remain anticoagulated until seen in the chest clinic, to which they should be referred shortly after diagnosis. All patients stated on anticoagulants must be given appropriate counselling and a yellow anticoagulant alert card, as well information specific to the specific anticoagulant they will be using. Patients with confirmed unprovoked PE must have a detailed physical examination including rectal and vaginal examinations to exclude underlying cancer, and undergo, as a minimum, CXR, uranalysis and, in the case of men, PSA. A CT or ultrasound examination of the abdomen and pelvis should also be considered together with mammograms. Anti-cardiolipin antibodies should also be checked. Lewisham and Greenwich NHS Trust Page 18 of 25

21 Patients with unprovoked PE should be considered for life long anticoagulation. Whilst awaiting confirmation of the PE, the patient canbe started on Rivaroxaban 15 mg bd. If PE confirmed, this should continue for 3 weeks after which 20 mg daily should be started (or 15 mg if renal impairment present and risk of bleeding outweighs risk of recurrent thrombosis) provided there are no contraindications and the initiation form is completed. See PE proforma and DOAC initiation documentation on Intranet, noting in particular the need to weigh patient accurately and check their renal function (including renal function according to Cockroft-Gault calculation) prior to the start of treatment. The patient will also need to undergo a baseline FBC and clotting screen, and any abnormalities discussed with the Haematology team unless trivial or easily explained otherwise. Patients with weight over 120 kg or less than 46 kg are not recommended for Rivaroxaban unless specifically initiated and supervised by a Consultant Haematologist and should receive Enoxaparin instead. Patients with PESI score I or II can be treated in the ambulatory setting, whereas patients with PESI III or more should be admitted. Consideration should be given to starting patients with PESI IV or V with Enoxaparin rather than Rivaroxaban Patients unsuitable for Rivaroxaban can usually be treated with Enoxaparin according to Guidelines, and should remain on Enoxaparin if their PE was cancer related. There is currently a site preference for QEH patients to be started on Enoxaparin pending DVT confirmation, after which a switch to Ribaroxaban is operated if the DVT is confirmed. Other patients unsuitable for Rivaroxaban who do not require long term enoxaparin therapy should, after appropriate counselling/written information and in the absence of contraindication, be started on a suitable warfarin loading regimen, noting that the Fenharty (10mg, 10mg, 5mg) regimen requires daily INR checks during induction and is not suitable for elderly/frail patients or those with abnormal baseline INR. The patient should also be referred to the anticoagulant clinic. The Enoxaparin is usually stopped when the INR reaches 2 or above, but may be continued until an INR of 3 if the patient requires a higher INR range. See also Anticoagulant prescription section of Drug Chart, Anticoagulant Clinic referral form, Anticoagulant Clinic SOP and Protocol for safe Discharge of patients on warfarin for further information. A thrombophilia screen will be required in patients under the age of 50 with unprovoked PE if there are plans to discontinue anticoagulation, and will be arranged by the Anticoagulant clinic after the patient has completed an appropriate period of anticoagulation. Treatment with Alteplase may also be considered in the persistently hypotensive patient, those with right ventricular failure or dysfunction, and those with very high pulmonary artery pressures. This requires careful assessment, usually by echocardiogram, and the relative risks considered. Such patients should be discussed with the consultant in charge before treatment. Also see British Thoracic Society guidelines and LGT Guideline on Alteplase for thrombolysis of PE for further information. Lewisham and Greenwich NHS Trust Page 19 of 25