Correction of thrombin generation in hemophilia plasma by recombinant factor V mutants

• Conditions: hemophilia; 10064477

• Registration Number: NL-OMON30248
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Consenting adult patients with hemophilia A
· 10 patients with severe hemophilia A (factor VIII < 1%)
· 10 patients with moderate hemophilia A (factor VIII 1-10%)
· 5 patients with hemophilia A and inhibiting antibodies towards factor VIII (>1.0 Bethesda Units)

Exclusion Criteria

Exclusion criteria
· Liver disease leading to other coagulopathies
· Anemia (Hb < 7.0 mmol/l)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Laboratory tests for activation of coagulation:<br /><br>- prothrombin activation fragment F1+2 (ELISA)<br /><br>- thrombin-antithrombin complexes (ELISA)<br /><br>- d-dimer (ELISA)<br /><br>- thrombin generation potential (amidolytic assay)<br /><br>- protein C dependent-thrombin generation potential (amidolytic assay)<br /><br>- routine coagulation tests (aPTT and PT)<br /><br>- factor V coagulant activity (one stage clotting test)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>none</p><br>