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Sponsored by: |
Northfield Laboratories |
---|---|
Information provided by: | Northfield Laboratories |
ClinicalTrials.gov Identifier: | NCT00076648 |
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 |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Shock Hemorrhage Shock, Hemorrhagic |
Pathologic Processes Shock Hemorrhage Shock, Hemorrhagic |