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

This study has been completed.

First Received: June 30, 2005 Last Updated: February 6, 2009 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00124293

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
Traumatic Brain Injury	Drug: activated recombinant human factor VII

MedlinePlus related topics: Bruises Traumatic Brain Injury

U.S. FDA Resources

Study Type:	Observational
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

Further study details as provided by Novo Nordisk:

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)

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: - Ages Eligible for Study: 18 Years - 85 Years

Contacts and Locations

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

Show 30 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Brett Skolnick, PhD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	F7CBI-1587
Study First Received:	June 30, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00124293 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Craniocerebral Trauma
Contusions
Wounds and Injuries
Disease Progression
Disorders of Environmental Origin

Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Craniocerebral Trauma
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin

Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries

ClinicalTrials.gov processed this record on May 06, 2009