Clot Formation and Clot Stability in Patients With Severe Haemophilia A

NCT ID: NCT00279578

Last Updated: 2006-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Hemophilia A

Keywords

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haemophilia A thrombelastography recombinant factor VIII thrombin generation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ReFacto (Recombinant factor VIII) and Tranexamic acid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Principal Investigators

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Anne-Mette Hvas, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Department of Clinical Biochemistry, Center for Haemophilia and Thrombosis

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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20050184

Identifier Type: -

Identifier Source: org_study_id