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

January 12, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

283

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Perth, Australia, WA, 6000
        • Novo Nordisk Investigational Site
  • Austria
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Novo Nordisk Investigational Site
  • France
      • Paris, France, 75651
        • Novo Nordisk Investigational Site
  • Germany
      • Aachen, Germany, 52074
        • Novo Nordisk Investigational Site
  • Israel
      • Jerusalem, Israel, 91240
        • Novo Nordisk Investigational Site
  • Singapore
      • Singapore, Singapore, 169608
        • Novo Nordisk Investigational Site
  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B29 6JD
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
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
Experimental: Activated recombinant human factor VII
Drug: activated 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7TRAUMA-2159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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