Use of Activated Recombinant FVII in Spinal Surgery

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

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