UnknownNot Applicable

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

Israel15 participantsStarted 2012-02

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency

Timeframe: 1 week

Trial details

NCT IDNCT01538160

SponsorSheba Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2015-07

Contact for this trial

Ophira Salomon, MD

97235302104 ophiras@sheba.health.gov.il

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