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NCT00279578 Clinical Trial

Clot Formation and Clot Stability in Patients With Severe Haemophilia A

Hemophilia A Clinical Trial

Official title:
Clot Formation and Clot Stability in Patients With Severe Haemophilia A - Effect of Recombinant Factor VIII and Tranexamic Acid

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00279578
Other study ID # 20050184
Secondary ID
Status Completed
Phase N/A
First received January 17, 2006
Last updated November 15, 2006
Start date January 2006
Est. completion date June 2006

Study information
Verified date November 2006
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

In the present study we are examining the clot formation and clot stability in patients with severe haemophilia A after they receive recombinat factor VIII and after addition of tranexamic acid. Our hypothesis is that addition of tranexamic increases the clot stability. The perpective of the study is to document whether it is relevant to use traneksamic acid in surgery in patients with severe haemophilia A.

Description:

In the present study we are examining the clot formation and clot stability in patients with severe haemophilia A after they receive recombinat factor VIII and after addition of tranexamic acid. Our hypothesis is that addition of tranexamic increases the clot stability. The perpective of the study is to document whether it is relevant to use traneksamic acid in surgery in patients with severe haemophilia A.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Severe haemophilia A

- Above 17 years old

- Thrombocyt count above 100 x 109/l within the past two years

Exclusion Criteria:

- Received recombinant factor VIII with in the past 3 days

- Inhibitor against recombinant factor VIII

- HIV-positive

- Ongoing treatment for hepatitis C

- Known kidney disease

- Allergy against Tranexamic acid

- Not able to give informed consent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ReFacto (Recombinant factor VIII) and Tranexamic acid

Locations
Country Name City State
Denmark Department of Clinical Biochemistry, Center for Haemophilia and Thrombosis Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clot stability
Secondary clot formation,thrombine generation
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