Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting
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
1 other identifier
interventional
N/A
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2004
CompletedFirst Posted
Study publicly available on registry
January 30, 2004
CompletedAugust 2, 2006
July 1, 2006
January 28, 2004
July 31, 2006
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients following trauma who have sustained blood loss and are in shock
You may not qualify if:
- Patients who have sustained unsurvivable injuries
- Patients who have severe head injury
- Pregnant females
- Patients found in cardiac arrest
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Scripps Mercy
San Diego, California, 92103, United States
UC San Diego Medical Center
San Diego, California, 92103, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
Christiana Hospital
Newark, Delaware, 19718, United States
Medical Center of Central Georgia
Macon, Georgia, 31201, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202, United States
Wishard Memorial Hospital
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Detroit Receiving Hospital
Detroit, Michigan, 48201, United States
Sinai Grace Hospital
Detroit, Michigan, 48201, United States
The Mayo Clinic
Rochester, Minnesota, 55905, United States
Albany Medical Center
Albany, New York, 12208, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0769, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
St. Luke's Regional Resource Trauma Center
Bethlehem, Pennsylvania, 18015, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Johnson City Medical Center
Johnson City, Tennessee, 37604, United States
University of Tennessee-Memphis
Memphis, Tennessee, 38163, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6315, United States
Memorial-Hermann Hospital
Houston, Texas, 77030, United States
University of Texas Health Science Center
San Antonio, Texas, 78284, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22066, United States
Sentara Norfolk Hospital
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298-0454, United States
West Virginia University/Jon Michael Moore Trauma Center
Morgantown, West Virginia, 26506, United States
Related Publications (1)
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.
PMID: 19228496DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 28, 2004
First Posted
January 30, 2004
Last Updated
August 2, 2006
Record last verified: 2006-07