Use of Activated Recombinant FVII in Spinal Surgery

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Spinal Fusion; Acquired Bleeding Disorder

Treatments: Drug: eptacog alfa (activated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00102037

F7SPIN-2180

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind