Use of Activated Recombinant FVII in Spinal Surgery

Evaluation of Safety of Activated Recombinant FVII as an Add-On Therapy in Spinal Surgery

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00102037

Enrollment

Registered

2005-01-20

Start date

2004-07-31

Completion date

2006-02-28

Last updated

2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Bleeding Disorder, Spinal Fusion

Brief 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.

Interventions

DRUGeptacog alfa (activated)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Safety variables	Within 30 days after surgery

Secondary

Measure	Time frame
Efficacy variables	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026