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

Phase 3
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
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (32)

Scripps Mercy

πŸ‡ΊπŸ‡Έ

San Diego, California, United States

UC San Diego Medical Center

πŸ‡ΊπŸ‡Έ

San Diego, California, United States

Denver Health Medical Center

πŸ‡ΊπŸ‡Έ

Denver, Colorado, United States

Christiana Hospital

πŸ‡ΊπŸ‡Έ

Newark, Delaware, United States

Medical Center of Central Georgia

πŸ‡ΊπŸ‡Έ

Macon, Georgia, United States

Loyola University Medical Center

πŸ‡ΊπŸ‡Έ

Maywood, Illinois, United States

Methodist Hospital of Indiana

πŸ‡ΊπŸ‡Έ

Indianapolis, Indiana, United States

Wishard Memorial Hospital

πŸ‡ΊπŸ‡Έ

Indianapolis, Indiana, United States

University of Kansas Medical Center

πŸ‡ΊπŸ‡Έ

Kansas City, Kansas, United States

University of Kentucky Medical Center

πŸ‡ΊπŸ‡Έ

Lexington, Kentucky, United States

Scroll for more (22 remaining)
Scripps Mercy
πŸ‡ΊπŸ‡ΈSan Diego, California, United States

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