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

Primary Purpose

Acquired Bleeding Disorder, Trauma

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
activated recombinant human factor VII
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Bleeding Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center

Outcomes

Primary Outcome Measures

Mortality and Morbidity

Secondary Outcome Measures

All cause mortality
Hospital-free days
Number of transfusion units
Days free of renal replacement therapy
ICU-free days
Days free of ventilator support

Full Information

First Posted
May 8, 2006
Last Updated
June 26, 2012
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00323570
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Study Start Date
May 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Bleeding Disorder, Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Primary Outcome Measure Information:
Title
Mortality and Morbidity
Time Frame
through day 30
Secondary Outcome Measure Information:
Title
All cause mortality
Title
Hospital-free days
Title
Number of transfusion units
Title
Days free of renal replacement therapy
Title
ICU-free days
Title
Days free of ventilator support

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartholomew Tortella, MD
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2975
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27835-6028
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140-5189
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2582
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234-6315
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Lackland AFB
State/Province
Texas
ZIP/Postal Code
78236-5300
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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