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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02061033
Other study ID # GHMJA2014
Secondary ID
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


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
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