Not Signed In -
Naloxone Injection |
Narcan |
Clinical Trial: Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting
This study is currently recruiting patients.
|
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 | Treatment or Intervention | Phase |
|---|---|---|
| Hemorrhagic Shock | Drug: Poly SFH-P Injection | Phase III |
MedlinePlus related topics: First Aid
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 above, Genders Eligible for Study: Both
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).
Location and Contact Information
California
UC San Diego Medical Center, San Diego, California, 92103, United States; Recruiting
Scripps Mercy, San Diego, California, 92103, United States; Recruiting
Colorado
Denver Health Medical Center, Denver, Colorado, 80204, United States; Recruiting
Delaware
Christiana Hospital, Newark, Delaware, 19718, United States; Recruiting
Illinois
Loyola University Medical Center, Maywood, Illinois, 60153, United States; Recruiting
Indiana
Wishard Memorial Hospital, Indianapolis, Indiana, 46202, United States; Recruiting
Methodist Hospital of Indiana, Indianapolis, Indiana, 46202, United States; Recruiting
Kentucky
University of Kentucky Medical Center, Lexington, Kentucky, 40536, United States; Recruiting
Minnesota
The Mayo Clinic, Rochester, Minnesota, 55905, United States; Recruiting
Ohio
MetroHealth Medical Center, Cleveland, Ohio, 44109, United States; Recruiting
Pennsylvania
Lehigh Valley Hospital, Allentown, Pennsylvania, 18103, United States; Recruiting
St. Luke's Regional Resource Trauma Center, Bethlehem, Pennsylvania, 18015, United States; Recruiting
Tennessee
University of Tennessee-Memphis, Memphis, Tennessee, 38163, United States; Recruiting
Texas
Memorial-Hermann Hospital, Houston, Texas, 77030, United States; Recruiting
University of Texas Health Science Center, San Antonio, Texas, 78284, United States; Recruiting
Virginia
Sentara Norfolk Hospital, Norfolk, Virginia, 23507, United States; Recruiting
Virginia Commonwealth University Medical Center, Richmond, Virginia, 23298-0454, United States; Recruiting
More Information
Record last reviewed: March 2005
Last Updated: March 4, 2005
Record first received: January 28, 2004
ClinicalTrials.gov Identifier: NCT00076648
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Naloxone Injection (Drug Digest)
- Narcan (Drug Digest)
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