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

Sponsored by:	Northfield Laboratories
Information provided by:	Northfield Laboratories
ClinicalTrials.gov Identifier:	NCT00076648

Purpose

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.

Condition	Intervention	Phase
Hemorrhagic Shock	Drug: Poly SFH-P Injection	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076648

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Locations

United States, California
UC San Diego Medical Center
San Diego, California, United States, 92103
Scripps Mercy
San Diego, California, United States, 92103
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
United States, Georgia
Medical Center of Central Georgia
Macon, Georgia, United States, 31201
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Methodist Hospital of Indiana
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
United States, Michigan
Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Sinai Grace Hospital
Detroit, Michigan, United States, 48201
United States, Minnesota
The Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0769
Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
St. Luke's Regional Resource Trauma Center
Bethlehem, Pennsylvania, United States, 18015
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
University of Tennessee-Memphis
Memphis, Tennessee, United States, 38163
Johnson City Medical Center
Johnson City, Tennessee, United States, 37604
United States, Texas
Memorial-Hermann Hospital
Houston, Texas, United States, 77030
University of Texas Health Science Center
San Antonio, Texas, United States, 78284
Brooke Army Medical Center
Fort Sam, Houston, Texas, United States, 78234-6315
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
Sentara Norfolk Hospital
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298-0454
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22066
United States, West Virginia
West Virginia University/Jon Michael Moore Trauma Center
Morgantown, West Virginia, United States, 26506

Sponsors and Collaborators

Northfield Laboratories

More Information

No publications provided by Northfield Laboratories

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Nov 7.

Study ID Numbers:	RTBSE-11-(N)
Study First Received:	January 28, 2004
Last Updated:	July 31, 2006
ClinicalTrials.gov Identifier:	NCT00076648 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Shock
Hemorrhage
Shock, Hemorrhagic

Additional relevant MeSH terms:

Pathologic Processes
Shock
Hemorrhage
Shock, Hemorrhagic

ClinicalTrials.gov processed this record on May 14, 2009