Clinical trial NCT00323570: Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma
Official title: A Multi-center, Randomized, 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 Refractory Bleeding in Severely Injured Trauma Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Acquired Bleeding Disorder
Trauma
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The purpose of this study is to evaluate the treatment of Recombinant Faction VIIa in Patients with Severe Bleeding Due to Trauma

Please note that this trial and trial F7TRAUMA-1711 (NCT00184548) have been merged.


Eligibility criteria: Inclusion Criteria:

* Trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard treatment

Primary outcomes:
measure: Mortality and Morbidity
timeFrame: through day 30
Secondary outcomes:
measure: All cause mortality
measure: Hospital-free days
measure: Number of transfusion units
measure: Days free of renal replacement therapy
measure: ICU-free days
measure: Days free of ventilator support
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Arizona
city: Los Angeles
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: California
city: Sacramento
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: California
city: Colorado Springs
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Colorado
city: Washington
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: District of Columbia
city: Gainesville
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Florida
city: Chicago
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Illinois
city: Maywood
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Illinois
city: Indianapolis
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Indiana
city: Louisville
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Kentucky
city: Portland
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Maine
city: Baltimore
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Maryland
city: Boston
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Massachusetts
city: Detroit
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Michigan
city: Springfield
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Missouri
city: St. Louis
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Missouri
city: Las Vegas
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Nevada
city: Camden
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New Jersey
city: Bronx
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New York
city: Brooklyn
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New York
city: Greenville
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: North Carolina
city: Akron
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Ohio
city: Cleveland
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Ohio
city: Columbus
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Ohio
city: Oklahoma City
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Oklahoma
city: Portland
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Oregon
city: Allentown
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Pennsylvania
city: Providence
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Rhode Island
city: Memphis
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Tennessee
city: Nashville
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Tennessee
city: Fort Sam Houston
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Texas
city: Lackland AFB
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Texas
city: Salt Lake City
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Utah
city: Madison
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Wisconsin
Study officials:
affiliation: Novo Nordisk A/S
name: Bartholomew Tortella, MD
role: STUDY_DIRECTOR
References: