Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury

This trial is conducted in Asia, Europe, Middle East, and North America. The primary objective of the trial is to evaluate the safety of Recombinant Activated Factor VII in patients with brain contusions. The secondary objective of the trial is to evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing early haemorrhagic progression in contusive brain injury.

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Key information

Conditions

Acquired Bleeding Disorder Trauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Montreal, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Contusive brain injury (including brain stem) diagnosed by history, clinical examination and confirmed by CT scan within 6 hours of onset
In British Columbia and Nova Scotia, subjects must be = 19 years.

Treatment and study plan

activated recombinant human factor VII

Drug

Primary outcomes

Evaluate the Safety of Recombinant Activated Factor VII in Subjects with Brain Contusions

Time frame: Within the first 15 days of injury

Secondary outcomes

Evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing haemorrhagic progression in brain contusions

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa (NovoSeven®/NiaStase®) in Subjects With Brain Contusions

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Jul 25, 2005
Registry last updated: Jan 12, 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