Hemophilia ANCT00279578
Clot Formation and Clot Stability in Patients With Severe Haemophilia A
A study testing ReFacto (Recombinant factor VIII) and Tranexamic acid in people with Hemophilia A, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- ReFacto (Recombinant factor VIII) and Tranexamic acid
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Jun 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe haemophilia A
- Above 17 years old
- Thrombocyt count above 100 x 109/l within the past two years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Biochemistry, Center for Haemophilia and Thrombosis
Aarhus, 8200
About this study
Official title: Clot Formation and Clot Stability in Patients With Severe Haemophilia A - Effect of Recombinant Factor VIII and Tranexamic Acid
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.
Read the 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.
- Conditions
- Hemophilia A
- Being tested
- ReFacto (Recombinant factor VIII) and Tranexamic acid
- Keywords
- haemophilia A, thrombelastography, recombinant factor VIII, thrombin generation
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReFacto (Recombinant factor VIII) and Tranexamic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clot stability
Secondary outcomes (1)
clot formation,thrombine generation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startJan 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Anne-Mette Hvas, MD, Ph.D., Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279578
- Sponsor's protocol ID
- 20050184
- Status last verified
- Nov 2006
- First submitted
- 17 Jan 2006
- Last updated
- 16 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clot Formation and Clot Stability in Patients With Severe Haemophilia A - Effect of Recombinant Factor VIII and Tranexamic Acid
- ClinicalTrials.gov ID
- NCT00279578
- Acronym / sponsor ID
- 20050184
- Conditions
- Hemophilia A
- Keywords
- haemophilia A, thrombelastography, recombinant factor VIII, thrombin generation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Jun 2006
- First posted
- 19 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe haemophilia A
- Above 17 years old
- Thrombocyt count above 100 x 109/l within the past two years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReFacto (Recombinant factor VIII) and Tranexamic acid | Drug | – |
Primary outcome
Clot stability
1 secondary outcome
clot formation,thrombine generation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Mette Hvas, MD, Ph.D. principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReFacto (Recombinant factor VIII) and Tranexamic acid in people with Hemophilia A, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clot stability. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2006.