Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00124293
First received: June 30, 2005
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

This study is conducted in North America. The purpose of this study is to evaluate the occurrence and severity of bleeding in brain injury and to identify important safety issues following traumatic brain injury.


Condition Intervention
Acquired Bleeding Disorder
Trauma
Drug: activated recombinant human factor VII

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi Centre Observational Study to Evaluate the Incidence and Magnitude of Haemorrhagic Progression of Cerebral Contusions and the Identification of Important Safety Issues Following Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Enrollment: 63
Study Start Date: October 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Factor VII Drug: activated recombinant human factor VII

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects were selected from a speciality practice group (Neurosurgery practices with a focus on head trauma. Subjects will have had a mild-to-moderate head injury and require hospitalization.

Criteria

Inclusion Criteria:

  • Ages Eligible for Study: 18 Years - 85 Years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124293

Locations
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
Canada
Mississauga, Canada, L4W 4XI
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Brett Skolnick, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00124293     History of Changes
Other Study ID Numbers: F7CBI-1587
Study First Received: June 30, 2005
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Additional relevant MeSH terms:
Brain Injuries
Blood Coagulation Disorders
Hemostatic Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on October 19, 2014