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Global Hemostatic Methods in Hemophilia and Von Willebrand's Disease (GHMHW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02061033
Recruitment Status : Unknown
Verified August 2016 by Jovan P. Antovic MD, PhD, Karolinska University Hospital.
Recruitment status was:  Recruiting
First Posted : February 12, 2014
Last Update Posted : August 31, 2016
The Swedish Society of Medicine
Karolinska Institutet
Information provided by (Responsible Party):
Jovan P. Antovic MD, PhD, Karolinska University Hospital

Brief Summary:

Patients with hemophilia who have the same level of deficient factor(s) may express different severity of clinical presentation and bleeding tendency. Therefore a test which could determine overall hemostasis rather than simple concentration of a single deficient factor may correlate better with clinical phenotype in these patients.

The investigators will therefore study the usefulness of global hemostatic methods (endogenous thrombin potential (ETP), overall hemostatic potential (OHP), fibrin clot structure) and microparticles in the prediction of severity of bleeding and estimation of response to the treatment in patients with hemophilia.

Since hemophilia patients on prophylactic treatment virtually do not bleed, additional patients who are treated on demand only will be included enabling to study possible modulatory effects of different hemostatic factors (particularly prothrombotic and thrombin activatable fibrinolysis inhibitor (TAFI)) on clinical presentation. The investigators will correlate both those factors and clinical severity with global hemostatic methods.

The investigators expect to prove that individual tailoring of the treatment, which may enable lowering the prophylactic dose of factor concentrate without increasing the risk of bleeding, is justified in some hemophilia patients. This approach would reduce the amount of necessary factor concentrate in certain patients and decrease the cost (which represents extensive burden for health care systems) of treatment without potential risk for the patients.

Condition or disease
Hemophilia A Hemophilia B Von Willebrand's Disease

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Study Start Date : March 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Primary Outcome Measures :
  1. Number of microparticles [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Citrated plasma and whole blood DNA samples

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 patients with moderate and severe hA, 30 patients with moderate and severe hB and 50 patients with VWD (primarily severe type I and type III) from hemophilia centers Stockholm, Sweden and Belgrade, Serbia.

Inclusion Criteria:

  • patients with bleeding disorders

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02061033

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Contact: Jovan P Antovic, MD, PhD +46 734 294447

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Karolinska University Hospital Recruiting
Stockholm, Sweden
Sponsors and Collaborators
Karolinska University Hospital
The Swedish Society of Medicine
Karolinska Institutet
Publications of Results:
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Responsible Party: Jovan P. Antovic MD, PhD, Associate professor, Consultant, Karolinska University Hospital Identifier: NCT02061033    
Other Study ID Numbers: GHMJA2014
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Keywords provided by Jovan P. Antovic MD, PhD, Karolinska University Hospital:
Hemophilia A
Hemophilia B
Von Willebrand's Disease
Endogen thrombin potential
Overall hemostatic potential
Fibrin clot
Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Blood Platelet Disorders