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

Severe Hemophilia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02324517
• Other study ID #: SHEBA-09-7563-GK-CTIL
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2014
• Last updated: December 18, 2014
• Start date: March 2010
• Est. completion date: June 2017

Study information

• Verified date: December 2014
• Source: Sheba Medical Center
• Contact: Gili Kenet, MD
• Phone: +972526666385
• Email: gili.kenet[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 90 Years

Eligibility

Inclusion Criteria:

• Informed consent

• Validated coagulation disorder

Exclusion Criteria:

• Not consenting to participate

• Multiple coagulopathies and comorbidities

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemophilia A
• Hemostatic Disorders
• Severe Hemophilia

Locations

Country	Name	City	State
Israel	Sheba Mediacl Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombin Generation Parameters pre and post therapy / spiking assays	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.	1 year from enrollment	No