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Clinical Trial 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.


Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01538160
Study type Interventional
Source Sheba Medical Center
Contact Ophira Salomon, MD
Phone 97235302104
Email ophiras@sheba.health.gov.il
Status Not yet recruiting
Phase N/A
Start date February 2012
Completion date July 2015