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Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting

Primary Purpose

Hemorrhagic Shock

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Poly SFH-P Injection
Sponsored by
Northfield Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhagic Shock

Eligibility Criteria

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

Inclusion Criteria: Adult patients following trauma who have sustained blood loss and are in shock Exclusion Criteria: Patients who have sustained unsurvivable injuries Patients who have severe head injury Pregnant females Patients found in cardiac arrest Patients who object to participation (e.g., religious grounds, wearing exclusion bracelet).

Sites / Locations

  • Scripps Mercy
  • UC San Diego Medical Center
  • Denver Health Medical Center
  • Christiana Hospital
  • Medical Center of Central Georgia
  • Loyola University Medical Center
  • Methodist Hospital of Indiana
  • Wishard Memorial Hospital
  • University of Kansas Medical Center
  • University of Kentucky Medical Center
  • Detroit Receiving Hospital
  • Sinai Grace Hospital
  • The Mayo Clinic
  • Albany Medical Center
  • Duke University Medical Center
  • University of Cincinnati Medical Center
  • MetroHealth Medical Center
  • Miami Valley Hospital
  • Lehigh Valley Hospital
  • St. Luke's Regional Resource Trauma Center
  • Penn State Milton S. Hershey Medical Center
  • Johnson City Medical Center
  • University of Tennessee-Memphis
  • Brooke Army Medical Center
  • Memorial-Hermann Hospital
  • University of Texas Health Science Center
  • University of Utah Health Sciences Center
  • LDS Hospital
  • Inova Fairfax Hospital
  • Sentara Norfolk Hospital
  • Virginia Commonwealth University Medical Center
  • West Virginia University/Jon Michael Moore Trauma Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 28, 2004
Last Updated
July 31, 2006
Sponsor
Northfield Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00076648
Brief Title
Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting
Official Title
A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Group Study Using Provisions for Exception From Informed Consent Requirements Designed to Evaluate the Safety and Efficacy of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme(R)] When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Northfield Laboratories

4. Oversight

5. Study Description

Brief Summary
This study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Poly SFH-P Injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients following trauma who have sustained blood loss and are in shock Exclusion Criteria: Patients who have sustained unsurvivable injuries Patients who have severe head injury Pregnant females Patients found in cardiac arrest Patients who object to participation (e.g., religious grounds, wearing exclusion bracelet).
Facility Information:
Facility Name
Scripps Mercy
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UC San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Medical Center of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Methodist Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wishard Memorial Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Sinai Grace Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
The Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0769
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
St. Luke's Regional Resource Trauma Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Johnson City Medical Center
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
University of Tennessee-Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam, Houston
State/Province
Texas
ZIP/Postal Code
78234-6315
Country
United States
Facility Name
Memorial-Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22066
Country
United States
Facility Name
Sentara Norfolk Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0454
Country
United States
Facility Name
West Virginia University/Jon Michael Moore Trauma Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19228496
Citation
Moore EE, Moore FA, Fabian TC, Bernard AC, Fulda GJ, Hoyt DB, Duane TM, Weireter LJ Jr, Gomez GA, Cipolle MD, Rodman GH Jr, Malangoni MA, Hides GA, Omert LA, Gould SA; PolyHeme Study Group. Human polymerized hemoglobin for the treatment of hemorrhagic shock when blood is unavailable: the USA multicenter trial. J Am Coll Surg. 2009 Jan;208(1):1-13. doi: 10.1016/j.jamcollsurg.2008.09.023. Epub 2008 Nov 7.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting

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