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

A Multi-center, Randomized, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ NiaStase®) in the Treatment of Refractory Bleeding in Severely Injured Trauma Patients

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00323570

Enrollment

Registered

2006-05-09

Start date

2006-05-31

Completion date

2007-06-30

Last updated

2012-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Bleeding Disorder, Trauma

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.

Interventions

DRUGactivated recombinant human factor VII

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Mortality and Morbidity	through day 30

Secondary

Measure	Time frame
Hospital-free days	—
Number of transfusion units	—
All cause mortality	—
ICU-free days	—
Days free of ventilator support	—
Days free of renal replacement therapy	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026