Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting

Status unconfirmed · Phase 3

Conditions studied: Hemorrhagic Shock

In brief

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.

Key facts

Study ID

NCT00076648

Run by

Northfield Laboratories

Last updated by the study team

2006-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Patients who object to participation (e.g., religious grounds, wearing exclusion bracelet).

Where it is running

• Scripps Mercy — San Diego, California, United States
• UC San Diego Medical Center — San Diego, California, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Christiana Hospital — Newark, Delaware, United States
• Medical Center of Central Georgia — Macon, Georgia, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Methodist Hospital of Indiana — Indianapolis, Indiana, United States
• Wishard Memorial Hospital — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Detroit Receiving Hospital — Detroit, Michigan, United States
• Sinai Grace Hospital — Detroit, Michigan, United States
• The Mayo Clinic — Rochester, Minnesota, United States
• Albany Medical Center — Albany, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Miami Valley Hospital — Dayton, Ohio, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• St. Luke's Regional Resource Trauma Center — Bethlehem, Pennsylvania, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Johnson City Medical Center — Johnson City, Tennessee, United States
• University of Tennessee-Memphis — Memphis, Tennessee, United States
• Brooke Army Medical Center — Fort Sam Houston, Texas, United States
• Memorial-Hermann Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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