Use of Activated Recombinant FVII in Spinal Surgery

Phase 2CompletedNCT00102037

Novo Nordisk A/S50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acquired Bleeding Disorder Spinal Fusion

Interventions

eptacog alfa (activated)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (14)

Novo Nordisk Investigational Site

Sacramento, California, United States

Novo Nordisk Investigational Site

San Francisco, California, United States

Outcomes

Primary Outcomes

Safety variables

Time frame: Within 30 days after surgery

Secondary Outcomes

Efficacy variables

Data from ClinicalTrials.gov

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