CompletedPhase 2

Use of Activated Recombinant FVII in Spinal Surgery

United States50 participantsStarted 2004-07

Plain-language summary

This trial is conducted in the United States of America (USA). The purpose of this clinical research trial is to understand how safe and effective Recombinant Activated FVII is for reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery.

Who can participate

Age range18 Years – 65 Years

SexALL

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

Inclusion Criteria: * Elective spinal fusion surgery. Exclusion Criteria: * History of thrombotic disorders (myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke, disseminated intravascular coagulation or peripheral artery thrombosis) * Any trauma within the last 3 months leading to hospitalization \> 24 hours * Angina or known coronary artery disease

What they're measuring

Safety variables

Timeframe: Within 30 days after surgery

Trial details

NCT IDNCT00102037

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-02

View on ClinicalTrials.gov More Acquired Bleeding Disorder trials