Skip to main content
OpenTrials
Completed

NCT Number: NCT01563523

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acquired Bleeding Disorder Trauma Wounds and Injuries

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Perth, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII

Drug

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

Placebo

Drug

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

Primary outcomes

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

Secondary outcomes

  1. Adverse Events

  2. 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)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Mar 27, 2012
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.