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

Completed

• Conditions: Trauma; Acquired Bleeding Disorder
• Interventions: Drug: activated recombinant human factor VII

• Registration Number: NCT00124293
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-06
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-07-26
• Study First Posted: 2005-07-27
• Primary Completion: 2005-11-23
• Study Completion: 2005-11-23
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Ages Eligible for Study: 18 Years - 85 Years

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Factor VII	activated recombinant human factor VII	-

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇦 Mississauga, Canada