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NCT00124293 Clinical Trial

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

Trauma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00124293
Other study ID # F7CBI-1587
Secondary ID
Status Completed
Phase N/A
First received June 30, 2005
Last updated February 23, 2017
Start date October 6, 2004
Est. completion date November 23, 2005

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date November 23, 2005
Est. primary completion date November 23, 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Ages Eligible for Study: 18 Years - 85 Years

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• activated recombinant human factor VII

Locations
Country Name City State
Canada Novo Nordisk Investigational Site Mississauga
United States Novo Nordisk Investigational Site Plainsboro New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada, 

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