Global Hemostatic Methods in Hemophilia and Von Willebrand's Disease

Hemophilia A Clinical Trial

— GHMHW  

Official title:

GLOBAL HEMOSTATIC METHODS IN HEMOPHILIA AND VON WILLEBRAND'S DISEASE CORRELATION WITH PATIENTS' CLINICAL STATUS AND USEFULNESS FOR TREATMENT MONITORING

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02061033
• Other study ID #: GHMJA2014
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2014
• Last updated: August 30, 2016
• Start date: March 2013
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Karolinska University Hospital
• Contact: Jovan P Antovic, MD, PhD
• Phone: +46 734 294447
• Email: Jovan.Antovic[@]ki.se
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• patients with bleeding disorders

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B
• Von Willebrand Diseases
• Von Willebrand's Disease

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet, The Swedish Society of Medicine

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Antovic JP, Mikovic D, Elezovic I, Holmström M, Wilkens M, Elfvinge P, Mahmoud Hourani Soutari N, Antovic A. Two global haemostatic assays as additional tools to monitor treatment in cases of haemophilia A. Thromb Haemost. 2012 Jul;108(1):21-31. doi: 10.1 — View Citation

Mobarrez F, Mikovic D, Antovic A, Antovic JP. Is a decrease of microparticles related to improvement of hemostasis after FVIII injection in hemophilia A patients treated on demand? J Thromb Haemost. 2013 Apr;11(4):697-703. doi: 10.1111/jth.12103. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of microparticles		5 years	No