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
Data Collection
Hemorrhage+2
+ Pathologic Processes
+ Shock
Treatment Study
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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).
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 32 locations
University of Kentucky Medical Center
Lexington, United StatesDetroit Receiving Hospital
Detroit, United StatesSinai Grace Hospital
Detroit, United States