Brief Title
Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders
Official Title
Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders, Including Hemophilia With Inhibitors
Brief Summary
Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other severe bleeding disorders could be monitored and guided based upon special clotting assays , eg thrombin generation and thromboelastography. In this study blood sampled from patients with bleeding disorders will be evaluated applying ex- vivo spiking assays with various coagulation concentrates to potentially address the feasibility of replacement /bypass agents/ combined therapy for future bleeding episodes. Patients that will be further treated by any regimen potentially suggested (as standard care- not within trial) will be thereafter followed , including repeated lab studies to assess the impact of therapy upon hemostasis.
Study Type
Observational
Primary Outcome
Thrombin Generation Parameters pre and post therapy / spiking assays
Condition
Severe Hemophilia
Study Arms / Comparison Groups
Hemophilia
Description: Patients with Hemophilia A OR B
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
300
Start Date
March 2010
Completion Date
June 2017
Primary Completion Date
June 2017
Eligibility Criteria
Inclusion Criteria: - Informed consent - Validated coagulation disorder Exclusion Criteria: - Not consenting to participate - Multiple coagulopathies and comorbidities
Gender
All
Ages
6 Months - 90 Years
Accepts Healthy Volunteers
No
Contacts
, +972526666385, [email protected]
Location Countries
Israel
Location Countries
Israel
Administrative Informations
NCT ID
NCT02324517
Organization ID
SHEBA-09-7563-GK-CTIL
Responsible Party
Principal Investigator
Study Sponsor
Sheba Medical Center
Study Sponsor
, ,
Verification Date
December 2014