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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01563523

Collaborator

(none)

283

Enrollment

Locations

Arms

Duration (Months)

31.4

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

283 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (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

Study Start Date :

Mar 1, 2002

Actual Primary Completion Date :

Oct 1, 2003

Actual Study Completion Date :

Oct 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Perth		Australia	WA, 6000
2	Novo Nordisk Investigational Site	Graz		Austria	8036
3	Novo Nordisk Investigational Site	Toronto	Ontario	Canada	M4N 3M5
4	Novo Nordisk Investigational Site	Paris		France	75651
5	Novo Nordisk Investigational Site	Aachen		Germany	52074
6	Novo Nordisk Investigational Site	Jerusalem		Israel	91240
7	Novo Nordisk Investigational Site	Singapore		Singapore	169608
8	Novo Nordisk Investigational Site	Cape Town	Western Cape	South Africa
9	Novo Nordisk Investigational Site	Birmingham		United Kingdom	B29 6JD