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

NCT ID: NCT00124293

Last Updated: 2017-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-06

Study Completion Date

2005-11-23

Brief Summary

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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

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Conditions

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Acquired Bleeding Disorder Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Factor VII

activated recombinant human factor VII

Intervention Type DRUG

Interventions

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activated recombinant human factor VII

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ages Eligible for Study: 18 Years - 85 Years
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Plainsboro, New Jersey, United States

Site Status

Novo Nordisk Investigational Site

Mississauga, , Canada

Site Status

Countries

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United States Canada

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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F7CBI-1587

Identifier Type: -

Identifier Source: org_study_id

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