Clinical trial NCT00184548: Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
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 Severely Injured Trauma Patients With Bleeding Refractory to Standard Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acquired Bleeding Disorder
Trauma
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity.

Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.

Detailed description: The decision to discontinue the F7TRAUMA-1711 trial is not due to any safety concerns. The result of the pre-planned futility analysis performed in June 2008 predicted a very low likelihood of reaching a successful outcome on the primary efficacy endpoint at the end of the trial and as a consequence, the company has decided to close the trial as this juncture.

Eligibility criteria: Inclusion Criteria:

* Trauma injury (blunt and/or penetrating) with evidence of active hemorrhage (torso and/or proximal lower extremity) refractory to blood component therapy and surgical haemostatic procedures at the time of randomisation

Primary outcomes:
measure: Mortality
timeFrame: from day 0 to 30
measure: Morbidity
timeFrame: from day 0 to day 30
Secondary outcomes:
measure: Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention
timeFrame: from day 0 to day 30
measure: Time to Death From Time of First Dose
timeFrame: from day 0 to day 30
measure: Number of Units of Transfused Red Blood Cells From Time of First Dose
timeFrame: from hour 0 to 24
measure: Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury
timeFrame: from hour 0 to 24
measure: Number of Units of All Allogeneic Transfusions From Time of First Dose
timeFrame: from hour 0 to 24
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New Jersey
city: Säo Paulo
country: Brazil
city: Prague
country: Czech Republic
city: Paris La défense cedex
country: France
city: Mainz
country: Germany
city: Vouliagment
country: Greece
city: Kowloon
country: Hong Kong
city: Budapest
country: Hungary
city: Rome
country: Italy
city: Alphen a/d Rijn
country: Netherlands
city: Sandton
country: South Africa
city: Madrid
country: Spain
city: Zurich
country: Switzerland
city: Crawley
country: United Kingdom
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: