Haemophilia A Clinical Trial
Official title:
Thrombin Generation Capacity of Patients With Severe Haemophilia Receiving Prophylaxis
Haemophilic arthropathy is one of the major complications of severe haemophilia. In order to
maintain plasma clotting factor activity levels above 1% and avoid spontaneous joint bleeds
and other serious bleeding events, prophylactic factor replacement therapy is used. Because
of the high cost and limited availability of clotting factor concentrates, dosing is a
crucial issue for prophylaxis therapy. Several studies reported a better correlation between
clinical bleeding tendency of patients with haemophilia and thrombin generation assay results
compared to FVIII/FIX levels. However there is no specific data showing that thrombin
generation may be a better indicator of the clinical efficacy of prophylaxis compared to the
conventional FVIII measurement.
The main objective of this open, multicentre, prospective study is to compare trough thrombin
generation capacity and FVIII levels in severe haemophilia patients and compare these two
laboratory results with:
- the number of spontaneous haemarthroses and other spontaneous serious bleeds occurred in
the last 6 months
- the number of additional FVIII units used in the last 6 months
This project requires no change in term of type of treatment : During the study, each patient
will be treated by his usual clotting factor at the usual regimen (frequency and dosage).
The clinical outcome with the usual prophylaxis regimen will be correlated to TGA results
n/a
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