Status:

COMPLETED

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

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Acquired Bleeding Disorder

Trauma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 contusi...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2006

    Estimated Enrollment :

    96 Patients enrolled

    Trial Details

    Trial ID

    NCT00123591

    Start Date

    January 1 2005

    End Date

    May 1 2006

    Last Update

    January 12 2017

    Active Locations (15)

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    Page 1 of 4 (15 locations)

    1

    Novo Nordisk Investigational Site

    Montreal, Canada, H3G 1A4

    2

    Novo Nordisk Investigational Site

    Helsinki, Finland, 00250

    3

    Novo Nordisk Investigational Site

    Hanover, Germany, 30625

    4

    Novo Nordisk Investigational Site

    New Dehli, New Delhi, India, 110029