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

Novo Nordisk A/S1 site in 1 country283 target enrollmentMarch 2002

ConditionsAcquired Bleeding Disorder Trauma

Interventionsactivated recombinant human factor VII placebo

Drugsactivated recombinant human factor VII placebo

Overview

Phase: Phase 2
Intervention: activated recombinant human factor VII
Conditions: Acquired Bleeding Disorder
Sponsor: Novo Nordisk A/S
Enrollment: 283
Locations: 1
Primary Endpoint: Number of PRBC (packed red blood cells) units (allogeneic/autologous) transfused
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2002

End Date

October 2003

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Activated recombinant human factor VII

Intervention: activated recombinant human factor VII

Placebo

Intervention: placebo

Outcomes

Primary Outcomes

Number of PRBC (packed red blood cells) units (allogeneic/autologous) transfused

Secondary Outcomes

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)