A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor
Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
Activated prothrombin complex concentrate (aPCC) and recombinant activated factor VII
(rFVIIa) are the only two drugs that are available to treat bleeds in haemophilia A patients
with high titer inhibitors. However, management of bleeds in these patients can be
challenging due to variation in response and lack of standardized methods to monitor the
effect. We hypothesized that significant increase in whole blood clot stability could be
achieved when tranexamic acid was given concomitantly with bypassing-agents while thrombin
generation remains unaffected. In this prospective crossover study the effect of aPCC and
rFVIIa with and without TXA on clot stability and thrombin generation capacity (ETP) were
studied, using thromboelastography (ROTEM) and thrombin generation assay (TGA), respectively.
In addition, the risk of thrombosis and disseminated intravascular coagulation (DIC) was
assessed.
Phase:
Phase 4
Details
Lead Sponsor:
Oslo University Hospital
Treatments:
Anti-inhibitor coagulant complex Factor VIII Tranexamic Acid