NCT01563523View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

283

Participants

Timeline

Start Date

March 31, 2002

Primary Completion Date

October 31, 2003

Study Completion Date

October 31, 2003

Conditions
Acquired Bleeding DisorderTrauma
Interventions
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

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

Trial Locations (9)

8036

Novo Nordisk Investigational Site, Graz

52074

Novo Nordisk Investigational Site, Aachen

75651

Novo Nordisk Investigational Site, Paris

91240

Novo Nordisk Investigational Site, Jerusalem

169608

Novo Nordisk Investigational Site, Singapore

WA, 6000

Novo Nordisk Investigational Site, Perth

M4N 3M5

Novo Nordisk Investigational Site, Toronto

Unknown

Novo Nordisk Investigational Site, Cape Town

B29 6JD

Novo Nordisk Investigational Site, Birmingham

Sponsors

Lead Sponsor

Novo Nordisk A/S
All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT01563523 - Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients | Biotech Hunter | Biotech Hunter