Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00323570
First received: May 8, 2006
Last updated: June 26, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Acquired Bleeding Disorder
Trauma
Drug: activated recombinant human factor VII
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Mortality and Morbidity [ Time Frame: through day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Designated as safety issue: No ]
  • Hospital-free days [ Designated as safety issue: No ]
  • Number of transfusion units [ Designated as safety issue: No ]
  • Days free of renal replacement therapy [ Designated as safety issue: No ]
  • ICU-free days [ Designated as safety issue: No ]
  • Days free of ventilator support [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323570

  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, United States, 85008
United States, California
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90033
Novo Nordisk Clinical Trial Call Center
Sacramento, California, United States, 95817
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Colorado Springs, Colorado, United States, 80909
United States, District of Columbia
Novo Nordisk Clinical Trial Call Center
Washington, District of Columbia, United States, 20010-2975
United States, Florida
Novo Nordisk Clinical Trial Call Center
Gainesville, Florida, United States, 32610
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32209
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33136
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60612
Novo Nordisk Clinical Trial Call Center
Maywood, Illinois, United States, 60153
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Louisville, Kentucky, United States, 40202
United States, Maine
Novo Nordisk Clinical Trial Call Center
Portland, Maine, United States, 04102
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Detroit, Michigan, United States, 48201
United States, Missouri
Novo Nordisk Clinical Trial Call Center
Springfield, Missouri, United States, 65804
Novo Nordisk Clinical Trial Call Center
St. Louis, Missouri, United States, 63110-0250
United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Camden, New Jersey, United States, 08103
United States, New York
Novo Nordisk Clinical Trial Call Center
Bronx, New York, United States, 10461
Novo Nordisk Clinical Trial Call Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Greenville, North Carolina, United States, 27835-6028
Novo Nordisk Clinical Trial Call Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Akron, Ohio, United States, 44304
Novo Nordisk Clinical Trial Call Center
Cleveland, Ohio, United States, 44109
Novo Nordisk Clinical Trial Call Center
Columbus, Ohio, United States, 43214
United States, Oklahoma
Novo Nordisk Clinical Trial Call Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Allentown, Pennsylvania, United States, 18103
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19102
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19140-5189
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19104
Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, United States, 15213-2582
United States, Rhode Island
Novo Nordisk Clinical Trial Call Center
Providence, Rhode Island, United States, 02903
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Memphis, Tennessee, United States, 38163
Novo Nordisk Clinical Trial Call Center
Nashville, Tennessee, United States, 37212
United States, Texas
Novo Nordisk Clinical Trial Call Center
Fort Sam Houston, Texas, United States, 78234-6315
Novo Nordisk Clinical Trial Call Center
Lackland AFB, Texas, United States, 78236-5300
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78229-3900
United States, Utah
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84143
United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Bartholomew Tortella, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00323570     History of Changes
Other Study ID Numbers: F7TRAUMA-1648
Study First Received: May 8, 2006
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Wounds and Injuries
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014