Brief Title
Global Hemostatic Methods in Hemophilia and Von Willebrand's Disease
Official Title
GLOBAL HEMOSTATIC METHODS IN HEMOPHILIA AND VON WILLEBRAND'S DISEASE CORRELATION WITH PATIENTS' CLINICAL STATUS AND USEFULNESS FOR TREATMENT MONITORING
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.
Study Type
Observational
Primary Outcome
Number of microparticles
Condition
Hemophilia A
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
180
Start Date
March 2013
Completion Date
December 2018
Primary Completion Date
December 2017
Eligibility Criteria
Inclusion Criteria: - patients with bleeding disorders Exclusion Criteria: - none
Gender
All
Ages
10 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, +46 734 294447, [email protected]
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT02061033
Organization ID
GHMJA2014
Responsible Party
Principal Investigator
Study Sponsor
Karolinska University Hospital
Collaborators
The Swedish Society of Medicine
Study Sponsor
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Verification Date
August 2016