Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders
- Conditions
- Severe Hemophilia
- Registration Number
- NCT02324517
- Lead Sponsor
- Sheba Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- Informed consent
- Validated coagulation disorder
- Not consenting to participate
- Multiple coagulopathies and comorbidities
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Thrombin Generation Parameters pre and post therapy / spiking assays 1 year from enrollment Thrombin Generation Parameters (Peak height, ETP) before and after spiking assays with procoagulant drugs will be compared for each patient separately and within each group of patients diagnosed with similar coagulation disorder.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sheba Mediacl Center
🇮🇱Ramat Gan, Israel