Clot Formation and Clot Stability in Patients With Severe Haemophilia A

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT00279578
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hemophilia A	Drug: ReFacto (Recombinant factor VIII) and Tranexamic acid	N/A

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.

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clot Formation and Clot Stability in Patients With Severe Haemophilia A - Effect of Recombinant Factor VIII and Tranexamic Acid
• Study Start Date: Jan 1, 2006
• Study Completion Date: Jun 1, 2006

Outcome Measures

Primary Outcome Measures

1. Clot stability []

Secondary Outcome Measures

1. clot formation,thrombine generation []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Biochemistry, Center for Haemophilia and Thrombosis	Aarhus		Denmark	8200

Sponsors and Collaborators

• University of Aarhus

Investigators

• Principal Investigator: Anne-Mette Hvas, MD, Ph.D., Aarhus University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00279578
• Other Study ID Numbers: 20050184
• First Posted: Jan 19, 2006
• Last Update Posted: Nov 16, 2006
• Last Verified: Nov 1, 2006

• Keywords provided by , ,: haemophilia A; thrombelastography; recombinant factor VIII; thrombin generation
• Additional relevant MeSH terms: Hemophilia A; Tranexamic Acid; Factor VIII

Study Results

No Results Posted as of Nov 16, 2006