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

Novo Nordisk

Status and phase

Completed

Phase 2

Conditions

Trauma

Acquired Bleeding Disorder

Treatments

Drug: activated recombinant human factor VII

Study type

Interventional

Funder types

Industry

Identifiers

NCT00123591

2004-000088-92 (EudraCT Number)

F7CBI-1600

Details and patient eligibility

About

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.

Enrollment

96 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.