Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00124293
Recruitment Status : Completed
First Posted : July 27, 2005
Last Update Posted : February 27, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Acquired Bleeding Disorder Trauma Drug: activated recombinant human factor VII

Layout table for study information
Study Type : Observational
Actual Enrollment : 63 participants
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
Actual Study Start Date : October 6, 2004
Actual Primary Completion Date : November 23, 2005
Actual Study Completion Date : November 23, 2005

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Factor VII Drug: activated recombinant human factor VII

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Inclusion Criteria:

  • Ages Eligible for Study: 18 Years - 85 Years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00124293

Layout table for location information
United States, New Jersey
Novo Nordisk Investigational Site
Plainsboro, New Jersey, United States, 08536
Novo Nordisk Investigational Site
Mississauga, Canada, L4W 4XI
Sponsors and Collaborators
Novo Nordisk A/S
Layout table for investigator information
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Layout table for additonal information
Responsible Party: Novo Nordisk A/S Identifier: NCT00124293    
Other Study ID Numbers: F7CBI-1587
First Posted: July 27, 2005    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Contusion
Hemostatic Disorders
Blood Coagulation 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
Wounds, Nonpenetrating