Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: March 23, 2012
Last updated: January 12, 2017
Last verified: January 2017
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
Drug: activated recombinant human factor VII
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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

Secondary Outcome Measures:
  • 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)

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


Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01563523

Novo Nordisk Investigational Site
Perth, Australia, WA, 6000
Novo Nordisk Investigational Site
Graz, Austria, 8036
Canada, Ontario
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Novo Nordisk Investigational Site
Paris, France, 75651
Novo Nordisk Investigational Site
Aachen, Germany, 52074
Novo Nordisk Investigational Site
Jerusalem, Israel, 91240
Novo Nordisk Investigational Site
Singapore, Singapore, 169608
South Africa
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa
United Kingdom
Novo Nordisk Investigational Site
Birmingham, United Kingdom, B29 6JD
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:

Responsible Party: Novo Nordisk A/S Identifier: NCT01563523     History of Changes
Other Study ID Numbers: F7TRAUMA-2159
Study First Received: March 23, 2012
Last Updated: January 12, 2017

Additional relevant MeSH terms:
Wounds and Injuries
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders processed this record on May 25, 2017