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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title:

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 Summary: 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.
Sponsor: Sheba Medical Center

Current Primary Outcome: Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency [ Time Frame: 1 week ]

End point to be assessed the degree of bleeding following major operation under rFVIIa


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sheba Medical Center

Dates:
Date Received: January 19, 2012
Date Started: February 2012
Date Completion: July 2015
Last Updated: February 22, 2012
Last Verified: February 2012