Trial record 3 of 7 for:    Open Studies | "von Willebrand Disease"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Karolinska University Hospital
Sponsor:
Collaborators:
The Swedish Society of Medicine
Karolinska Institutet
Information provided by (Responsible Party):
Jovan P. Antovic MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT02061033
First received: February 7, 2014
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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
Hemophilia A
Hemophilia B
Von Willebrand's Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: GLOBAL HEMOSTATIC METHODS IN HEMOPHILIA AND VON WILLEBRAND'S DISEASE CORRELATION WITH PATIENTS' CLINICAL STATUS AND USEFULNESS FOR TREATMENT MONITORING

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Number of microparticles [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Citrated plasma and whole blood DNA samples


Estimated Enrollment: 180
Study Start Date: March 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • patients with bleeding disorders

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061033

Contacts
Contact: Jovan P Antovic, MD, PhD +46 734 294447 Jovan.Antovic@ki.se

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden
Sponsors and Collaborators
Karolinska University Hospital
The Swedish Society of Medicine
Karolinska Institutet
  More Information

Publications:
Responsible Party: Jovan P. Antovic MD, PhD, Associate professor, Consultant, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02061033     History of Changes
Other Study ID Numbers: GHMJA2014
Study First Received: February 7, 2014
Last Updated: February 11, 2014
Health Authority: Sweden: Institutional Review Board

Keywords provided by Karolinska University Hospital:
Hemophilia A
Hemophilia B
Von Willebrand's Disease
Endogen thrombin potential
Overall hemostatic potential
Microparticles
Fibrin clot

Additional relevant MeSH terms:
Von Willebrand Diseases
Hemophilia B
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Blood Platelet Disorders
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014