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Clot Formation and Clot Stability in Patients With Severe Haemophilia A

Primary Purpose

Hemophilia A

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ReFacto (Recombinant factor VIII) and Tranexamic acid
Sponsored by
University of Aarhus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia A focused on measuring haemophilia A, thrombelastography, recombinant factor VIII, thrombin generation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Clinical Biochemistry, Center for Haemophilia and Thrombosis

Outcomes

Primary Outcome Measures

Clot stability

Secondary Outcome Measures

clot formation,thrombine generation

Full Information

First Posted
January 17, 2006
Last Updated
November 15, 2006
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT00279578
Brief Title
Clot Formation and Clot Stability in Patients With Severe Haemophilia A
Official Title
Clot Formation and Clot Stability in Patients With Severe Haemophilia A - Effect of Recombinant Factor VIII and Tranexamic Acid
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A
Keywords
haemophilia A, thrombelastography, recombinant factor VIII, thrombin generation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ReFacto (Recombinant factor VIII) and Tranexamic acid
Primary Outcome Measure Information:
Title
Clot stability
Secondary Outcome Measure Information:
Title
clot formation,thrombine generation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Mette Hvas, MD, Ph.D.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Biochemistry, Center for Haemophilia and Thrombosis
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

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Clot Formation and Clot Stability in Patients With Severe Haemophilia A

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