NCT01563523

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2002

Geographic Reach
8 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

March 23, 2012

Last Update Submit

January 12, 2017

Conditions

Acquired Bleeding DisorderTrauma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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)

Study Arms (2)

Activated recombinant human factor VII

EXPERIMENTAL
Drug: activated recombinant human factor VII

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

activated recombinant human factor VIIDRUG

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

Activated recombinant human factor VII
placeboDRUG

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

Placebo

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novo Nordisk Investigational Site

Perth, WA, 6000, Australia

Location

Novo Nordisk Investigational Site

Graz, 8036, Austria

Location

Novo Nordisk Investigational Site

Toronto, Ontario, M4N 3M5, Canada

Location

Novo Nordisk Investigational Site

Paris, 75651, France

Location

Novo Nordisk Investigational Site

Aachen, 52074, Germany

Location

Novo Nordisk Investigational Site

Jerusalem, 91240, Israel

Location

Novo Nordisk Investigational Site

Singapore, 169608, Singapore

Location

Novo Nordisk Investigational Site

Cape Town, Western Cape, South Africa

Location

Novo Nordisk Investigational Site

Birmingham, B29 6JD, United Kingdom

Location

Related Publications (9)

  • Rossaint R, Christensen MC, Choong PI, Boffard KD, Riou B, Rizoli S, Kluger Y, Lefering R, Morris S; NovoSeven(R) Trauma Study Group. Cost-Effectiveness of Recombinant Activated Factor VII as Adjunctive Therapy for Bleeding Control in Severely Injured Trauma Patients in Germany. Eur J Trauma Emerg Surg. 2007 Oct;33(5):528-38. doi: 10.1007/s00068-007-6210-x. Epub 2007 Jul 20.

    PMID: 26814938RESULT

  • Boffard KD, Riou B, Warren B, Choong PI, Rizoli S, Rossaint R, Axelsen M, Kluger Y; NovoSeven Trauma Study Group. Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo-controlled, double-blind clinical trials. J Trauma. 2005 Jul;59(1):8-15; discussion 15-8. doi: 10.1097/01.ta.0000171453.37949.b7.

    PMID: 16096533RESULT

  • Rizoli SB, Boffard KD, Riou B, Warren B, Iau P, Kluger Y, Rossaint R, Tillinger M; NovoSeven Trauma Study Group. Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials. Crit Care. 2006;10(6):R178. doi: 10.1186/cc5133.

    PMID: 17184516RESULT

  • Morris S, Ridley S, Munro V, Christensen MC. Cost effectiveness of recombinant activated factor VII for the control of bleeding in patients with severe blunt trauma injuries in the United Kingdom. Anaesthesia. 2007 Jan;62(1):43-52. doi: 10.1111/j.1365-2044.2006.04896.x.

    PMID: 17156226RESULT

  • Champion HR, Fingerhut A, Escobar MA, Weiskopf RB. The role of data and safety monitoring in acute trauma resuscitation research. J Am Coll Surg. 2007 Jan;204(1):73-83. doi: 10.1016/j.jamcollsurg.2006.10.024.

    PMID: 17189115RESULT

  • Klitgaard T, Tabanera y Palacios R, Boffard KD, Iau PT, Warren B, Rizoli S, Rossaint R, Kluger Y, Riou B; NovoSeven Trauma Study Group. Pharmacokinetics of recombinant activated factor VII in trauma patients with severe bleeding. Crit Care. 2006;10(4):R104. doi: 10.1186/cc4977.

    PMID: 16859505RESULT

  • Kluger Y, Riou B, Rossaint R, Rizoli SB, Boffard KD, Choong PI, Warren B, Tillinger M. Safety of rFVIIa in hemodynamically unstable polytrauma patients with traumatic brain injury: post hoc analysis of 30 patients from a prospective, randomized, placebo-controlled, double-blind clinical trial. Crit Care. 2007;11(4):R85. doi: 10.1186/cc6092.

    PMID: 17686152RESULT

  • Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.

    PMID: 18580208RESULT

  • Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919-33. doi: 10.1111/j.1537-2995.2006.00824.x.

    PMID: 16734808RESULT

Related Links

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2012

First Posted

March 27, 2012

Study Start

March 1, 2002

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations

SG(1)AU(1)FR(1)IL(1)DE(1)ZA(1)GB(1)CA(1)