A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery

Not Applicable

• Conditions: Hemophilia C

• Registration Number: NCT01538160
• Lead Sponsor: Sheba Medical Center

Brief Summary

Lately the investigators found that patients with severe factor XI deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic agent. These results encourage us to apply this treatment in clinical trial setting to patients with severe factor XI deficiency undergoing surgery instead of blood product.

Detailed Description

Eligible patients will be those with severe factor XI deficiency who agree to participate in the study . The treatment does not apply to patients requiring coronary artery bypass or other vascular surgery.

Study Timeline

• Study First Submitted: 2012-01-19
• Status Verified: 2012-02
• Study Start: 2012-02
• Study First Submitted QC: 2012-02-22
• Last Update Submitted: 2012-02-22
• Study First Posted: 2012-02-23
• Last Update Posted: 2012-02-23
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• patients with severe factor XI deficiency who will give informed consent to participate in the study

Exclusion Criteria

• patients with atherosclerosis disease i.e. unstable angina pectoris or recent stroke
• Patients who required aorto-coronary bypass or any vascular surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency	1 week	End point to be assessed the degree of bleeding following major operation under rFVIIa

Trial Locations

Locations (2)

Sheba Medical Center; 🇮🇱 Tel Hashomer, Ramat-Gan, Israel

Ophira Salomon; 🇮🇱 Ramat -Gan, Israel