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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: June 30, 2005
Last updated: February 23, 2017
Last verified: February 2017
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
Actual Study Start Date: October 6, 2004
Study Completion Date: November 23, 2005
Primary Completion Date: November 23, 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Factor VII Drug: activated recombinant human factor VII


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
  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 identifier: NCT00124293

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
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00124293     History of Changes
Other Study ID Numbers: F7CBI-1587
Study First Received: June 30, 2005
Last Updated: February 23, 2017

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
Wounds, Nonpenetrating processed this record on August 16, 2017