Use of Activated Recombinant FVII in Spinal Surgery

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.

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Key information

Conditions

Acquired Bleeding Disorder Spinal Fusion

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Sacramento, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eptacog alfa (activated)

Drug

Other names: activated recombinant human factor VII

Primary outcomes

Safety variables

Time frame: Within 30 days after surgery

Secondary outcomes

Efficacy variables

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Jan 20, 2005
Registry last updated: Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed