Registry for haemophiliacs in France : FranceCoag Network. Thierry Lambert, MD
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1 Registry for haemophiliacs in France : FranceCoag Network Thierry Lambert, MD Haemophilia Treatment Center,, Bicêtre
2 History Before 1994: nothing 1994: set up of "Suivi" thérapeutique National des Hémophiles" " (SNH) National prospective multicenter cohort study Anonymous Limited to haemophilia A or B patients Mains objectives : Pharmacovigilance of clotting factor concentrates for haemophiliacs, inhibitor s s research projects. Yearly or visits (definited( calendar), specific blood sampling for lab tests, plasma, serum and cells preservation. Intermediate quarterly visits for PUP'S. Patients or parents signature Supported by French health authorities and coordinated by Inserm (research organism) 100% monitoring of data
3 Assessment of SNH (Y2000) (1) T Calvez et al, Haemophilia, 2001
4 Assessment of SNH (Y2000) (2) "Only" 1240 patients enrolled (estimated population: > 4000) Unequal representation of regions Difficulty to proper follow-up Tough data collection and paperwork No use of frozen samples Increasing cost of blood sample processing Other congenital coagulation proteins defects? Need to evolve
5 Birth of FranceCoag Network Initiated 28 Jan 2003 Two main objectives : 1. Exhaustive knowledge of haemophiliac's population in France (namely: geographic breakdown, associated pathologies, clotting factor concentrates consumption, healthcare system requirements ) and follow-up of patients with congenital bleeding disorders due to clotting factor deficiency 2. Tool for sanitary surveillance of these patients receiving clotting factor concentrates. Research objectives (notably Pups Protocol)
6 National, prospective multicenter cohort study. Observational study: no specific scheduled visits or blood sampling. No signed consent. Anonymous. Alleviated data collection Optional signed informed consent for serum, plasma and cell preservation every 3 years. Every severe congenital deficiency of clotting factor may be included (except moderate and mild form for haemophilia) Opens a specific cohort for pup's haemophiliacs. Alleviated data monitoring More patients for the same cost Supported by French health authorities and initially coordinated by Inserm,, now by National Institute for Public Health Surveillance (InVS)
7 Organization Steering committee: InVS members (coordinating( center) Authorities of health representative Head of Regional Treatment Centres physicians COMETH physicians INSERM delegate Agency of sanitary safety representative Haemophilia patient's association representatives Scientific experts Several missions : Propose and decide on evolutions of the project, animate the Network, estimate the research projects, etc. 5 meetings a year Report of each steering committee meeting sent to all participant physicians.
8 Scientific Aspects Any physician can submit a research project to the steering committee, using data and eventually biological samples of the FranceCoag cohort Project is reviewed by steering committee and other experts if necessary, prior to acceptation 3 international publications at now 3 running studies
9 Rythm of inclusions and follow-up 3300 update to nov Inclusions ou followed Patients included Followed patients Time since the starting of project (months)
10 Inclusions and follow-up up, per year 15 dec 2004 update Evolution of inclusions and follow-up visits Total Inclusions Hemophilia * Von Willebrand disease Others (89 %) 239 (8 %) 97 (3 %) Total Follow-up Hemophilia Von Willebrand disease Others (93 %) 48 (4 %) 31 (3 %) Total
11
12 Repartition by pathologies Maladie Nombre de patients inclus (n) (%) Afibrinogénémie Déficit en Facteur II 0 - Déficit en Facteur V Déficit en Facteur VII Déficit en Facteur VIII Déficit en Facteur IX Déficit en Facteur X Déficit en Facteur XI Déficit en Facteur XIII Déficit en Facteur Willebrand Total Inclusions
13 Assessment Good participation of French HTC's (36 centres participating, 90 physicians) Adhesion of patients 194 Pup's included in Pups Protocol Useful tool of communication and information for haemophiliac's physicians Data collection is moving to electronic means We have faith in development of new research projects issued from this registry
14 How to know more about FranceCoag Network? Visit Web Site :
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