CompletedPhase 2

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

Canada, Finland, Germany96 participantsStarted 2005-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Within the first 15 days of injury

Trial details

NCT IDNCT00123591

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-05

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