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

Novo Nordisk A/S96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acquired Bleeding Disorder Trauma

Interventions

activated recombinant human factor VIIDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

Novo Nordisk Investigational Site

Montreal, Canada

Novo Nordisk Investigational Site

Helsinki, Finland

Novo Nordisk Investigational Site

Hanover, Germany

Outcomes

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

Data from ClinicalTrials.gov

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