A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery (rFVIIa)
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ClinicalTrials.gov Identifier: NCT01538160
Recruitment Status : Unknown
Verified February 2012 by Sheba Medical Center. Recruitment status was: Not yet recruiting
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.
Condition or disease
Drug: recombinant factor VIIa
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.
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
patients with severe factor XI deficiency who will give informed consent to participate in the study
patients with atherosclerosis disease i.e. unstable angina pectoris or recent stroke
Patients who required aorto-coronary bypass or any vascular surgery