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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01563523
First received: March 23, 2012
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Acquired Bleeding Disorder
Trauma
Drug: activated recombinant human factor VII
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number of PRBC (packed red blood cells) units (allogeneic/autologous) transfused [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]

Enrollment: 283
Study Start Date: March 2002
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563523

Locations
Australia
Perth, Australia, WA, 6000
Canada, Ontario
Toronto, Ontario, Canada, M4N 3M5
France
Paris, France, 75651
Germany
Aachen, Germany, 52074
Israel
Jerusalem, Israel, 91120
Singapore
Singapore, Singapore, 169608
South Africa
Cape Town, Western Cape, South Africa
United Kingdom
Birmingham, United Kingdom, B29 6JD
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Christian Meyer Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01563523     History of Changes
Other Study ID Numbers: F7TRAUMA-2159
Study First Received: March 23, 2012
Last Updated: March 27, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Singapore: Health Sciences Authority
South Africa: Medicines Control Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Wounds and Injuries
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014