Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients

A Multi-centre, Randomised, 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 Bleeding in Severely Injured Trauma Subjects

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01563523

Enrollment

283

Registered

2012-03-27

Start date

2002-03-31

Completion date

2003-10-31

Last updated

2017-01-13

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 Africa, Asia, Europe, Oceania and North America. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII given in conjunction with standard therapy in the treatment of massive bleeding in subjects with severe blunt and/or penetrating trauma injury.

Interventions

DRUGactivated recombinant human factor VII

Standard therapy in conjunction with three single doses of rFVIIa administered over a 3 hour period. Administered once the subject has received 8 units of PRBC

DRUGplacebo

Standard therapy in conjunction with three single doses of placebo administered over a 3 hour period. Administered once the subject has received 8 units of PRBC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Informed consent obtained from the subject and/or his/her legally authorised representative (LAR) before any trial-related activities * Injury(ies) due to a blunt and or penetrating trauma * Receipt of 6 units of PRBC within a 4 hour period following admittance to the trauma centre * Receipt of 8 units of PRBC upon administration of trial drug

Exclusion criteria

* Prehospital cardiac arrest * Cardiac arrest in the ER or OR * Gunshot wound to the head * Glasgow Coma Scale below 8 * Base deficit of above 15 mEq/l or severe acidosis * Transfusion of 8 units or more of PRBC prior to arrival in trauma centre

Design outcomes

Primary

Measure	Time frame
Number of PRBC (packed red blood cells) units (allogeneic/autologous) transfused	—

Secondary

Measure	Time frame
Adverse Events	—
Changes in coagulation related parameters: APTT (activated partial thromboplastin time), fibrinogen, D-dimers, anti thrombin-III, F1+2 (prothrombin fragment 1+2) and TAT (thrombin anti thrombin complex)	—

Countries

Australia, Austria, Canada, France, Germany, Israel, Singapore, South Africa, United Kingdom

Outcome results

None listed

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