Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma

Phase 3

Withdrawn

• Conditions: Trauma; Acquired Bleeding Disorder

• Registration Number: NCT00323570
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in the United States of America (USA). The purpose of this study is to evaluate the treatment of Recombinant Faction VIIa in Patients with Severe Bleeding Due to Trauma

Please note that this trial and trial F7TRAUMA-1711 (NCT00184548) have been merged.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-08
• Study First Submitted QC: 2006-05-08
• Study First Posted: 2006-05-09
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard treatment

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mortality and Morbidity	through day 30

Secondary Outcome Measures

Name	Time	Method
All cause mortality
Hospital-free days
Number of transfusion units
Days free of renal replacement therapy
ICU-free days
Days free of ventilator support

Trial Locations

Locations (1)

Novo Nordisk Clinical Trial Call Center; 🇺🇸 Madison, Wisconsin, United States