NCT00124293

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2004

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 27, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2005

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

June 30, 2005

Last Update Submit

February 23, 2017

Conditions

Acquired Bleeding DisorderTrauma

Study Arms (1)

Factor VII

Drug: activated recombinant human factor VII

Interventions

activated recombinant human factor VIIDRUG
Factor VII

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Ages Eligible for Study: 18 Years - 85 Years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novo Nordisk Investigational Site

Plainsboro, New Jersey, 08536, United States

Location

Novo Nordisk Investigational Site

Mississauga, L4W 4XI, Canada

Location

Related Links

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 27, 2005

Study Start

October 6, 2004

Primary Completion

November 23, 2005

Study Completion

November 23, 2005

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

US(1)CA(1)