NCT02324517

Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders

Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders, Including Hemophilia With Inhibitors

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 6 Months – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Hemophilia

Timeline

• Start date: 2010-03-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2014-12-24
• Last updated: 2014-12-24

Locations

1 site across 1 country: Israel