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Clot Formation and Clot Stability in Patients With Severe Haemophilia A

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00279578
First received: January 17, 2006
Last updated: November 15, 2006
Last verified: November 2006
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Clot stability

Secondary Outcome Measures:
  • clot formation,thrombine generation

Estimated Enrollment: 8
Study Start Date: January 2006
Estimated Study Completion Date: June 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279578

Locations
Denmark
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00279578     History of Changes
Other Study ID Numbers: 20050184
Study First Received: January 17, 2006
Last Updated: November 15, 2006
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
haemophilia A
thrombelastography
recombinant factor VIII
thrombin generation

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Tranexamic Acid
 Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics

ClinicalTrials.gov processed this record on May 16, 2013