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Clot Formation and Clot Stability in Patients With Severe Haemophilia A

Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia A

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

Phase: N/A

Status: Completed

Sponsored by: University of Aarhus

Official(s) and/or principal investigator(s):
Anne-Mette Hvas, MD, Ph.D., Principal Investigator, Affiliation: Aarhus University Hospital

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.

Clinical Details

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

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

Primary outcome: Clot stability

Secondary outcome: clot formation,thrombine generation

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Locations and Contacts

Department of Clinical Biochemistry, Center for Haemophilia and Thrombosis, Aarhus 8200, Denmark
Additional Information

Starting date: January 2006
Last updated: November 15, 2006

Page last updated: August 23, 2015

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