Recombinant Factor VII vs Cryoprecipitate. Dr. M. Truter Moderator: Prof. Pretorius

Transcription

1 Recombinant Factor VII vs Cryoprecipitate Dr. M. Truter Moderator: Prof. Pretorius

2 Discussion with Dr. J. Potgieter (Haematology) No articles on Recombinant factor VII vs Cryoprecipitate Different indications Different mechanisms to stop bleeding

3 Cryoprecipitate Prepared from plasma Contains Fibrinogen Von Willebrand factor Factor VIII Factor XIII Fibronectin

4 Cryoprecipitate Indications Bleeding or immediately prior to an invasive procedure in patients with hypofibrinogemia (<100 mg/dl) Sometimes useful if Plt dysfx associated with renal failure does not respond to dialysis or DDAVP Dosage Average 1 bag/10kg Cost R150-R300/per bag

5 Recombinant Factor VII Factor VIIa known as NovoSeven Factor VIIa is an initiator of thrombin generation. Indications Licensed for use in haemophiliacs with antibodies to factor VIII Use in trauma and haemorrhage is on a compassionate basis. Dosage 90 µg/kg Half-life is 2 hours and repeated dosage usually required Cost About R for 3 dosis

6 Recombinant Factor VII vs Cryoprecipitate

7 Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials Sandro B Rizoli1, Kenneth D Boffard2, Bruno Riou3, Brian Warren4, Philip Iau5, Yoram Kluger6, Rolf Rossaint7, Michael Tillinger8 and the NovoSeven Trauma Study Group

8 Methods Randomized, placebo-controlled, double-blind trial 23 institutions in 8 countries 2 parallel treatment arms (rvii/placebo) in 2 separate trauma populations (blunt and penetrating)

9 Methods Eligible patients within each trauma population were equally randomly assigned Received 3 intravenous injection of rfvii (200,100 and 100 μg/kg) 3 placebo injections Administered 1 - Immediately after transfusion of the 8 th unit of RBC 2-1 hour after first dose 3-3 hours after first dose

10 Methods Inclusion 6 or > RBC s within 4 hour period 16 years or > (or legally of age according to local law) < 65 years

11 Methods Exclusion Cardiac arrest pre-hospital/emergency department/operating rooms prior to trial drug administration GSW head GCS < 8, unless normal CTB Base deficit > 15 meq/l ph<7.00 T/F 8 or > RBCs prior to arrival Injury sustained > 12hrs before randamization

12 Methods No consensus definition currently exists that adequately defines coagulopathy This study definition: Ongoing bleeding requiring use of t/f with FFPs and RBCs at a ratio of 1 or > FFP for every 4 units of RBCs, and/or FFP with whole blood, and/or t/f of platelets, and or t/f of cryoprecipitate

13 Methods TBI excluded: Mandates a different fluid and transfusion management Higher risk of coagulopathy

14 Methods Primary endpoint Number of RBC s t/f during 48 hours after first dose of trial product Other assessments Requirement of other transfusion products Massive t/f (> 20 units RBCs, including initial 8) Time on ventilator Time in ICU Serious adverse events MOF, ARDS, Death Recorded up to day 30 Separate analysis of patients died within 48 hours

15 Results Out of 277 patients 136 coagulopathic patients 76 placebo 60 rfvii

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22 Conclusion Patients received particular benefit from rviia therapy Reduction in blood transfusion Reduction in ARDS and/or MOF Did not increase thromboembolic complications This study supports the concept of considering rviia for the management of trauma patients with coagulopathy

23 Criticism Positive RCT Good numbers Negative? Intervention? Bias