Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting
- Conditions
- Hemorrhagic Shock
- Registration Number
- NCT00076648
- Lead Sponsor
- Northfield Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
- Adult patients following trauma who have sustained blood loss and are in shock
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Brooke Army Medical Center
🇺🇸Fort Sam, Houston, Texas, United States
Scripps Mercy
🇺🇸San Diego, California, United States
St. Luke's Regional Resource Trauma Center
🇺🇸Bethlehem, Pennsylvania, United States
Medical Center of Central Georgia
🇺🇸Macon, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Sentara Norfolk Hospital
🇺🇸Norfolk, Virginia, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
UC San Diego Medical Center
🇺🇸San Diego, California, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
Wishard Memorial Hospital
🇺🇸Indianapolis, Indiana, United States
Detroit Receiving Hospital
🇺🇸Detroit, Michigan, United States
Sinai Grace Hospital
🇺🇸Detroit, Michigan, United States
The Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Methodist Hospital of Indiana
🇺🇸Indianapolis, Indiana, United States
Memorial-Hermann Hospital
🇺🇸Houston, Texas, United States
University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
Christiana Hospital
🇺🇸Newark, Delaware, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Tennessee-Memphis
🇺🇸Memphis, Tennessee, United States
Johnson City Medical Center
🇺🇸Johnson City, Tennessee, United States
West Virginia University/Jon Michael Moore Trauma Center
🇺🇸Morgantown, West Virginia, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States