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



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

For Condition: Hemorrhagic Shock
Status: Recruiting
Sponsor(s): Northfield Laboratories ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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).
Total Enrollment: 

Location and Contact Information:

Methodist Hospital of Indiana *Recruiting*
Indianapolis,  Indiana,  46202
United States
Recruiting Rick  Lowry 317-962-6144

MetroHealth Medical Center *Recruiting*
Cleveland,  Ohio,  44109
United States
Recruiting Carolyn  Smith 216-778-4199

Scripps Mercy *Recruiting*
San Diego,  California,  92103
United States
Recruiting Beth  Romeril 619-543-6173

Memorial-Hermann Hospital *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Belanie  Peavy-Abbs 713-500-7277

University of Kentucky Medical Center *Recruiting*
Lexington,  Kentucky,  40536
United States
Recruiting Anna  Rockich 859-323-6346

Lehigh Valley Hospital *Recruiting*
Allentown,  Pennsylvania,  18103
United States
Recruiting Victoria  Sabella 610-402-1286

Christiana Hospital *Recruiting*
Newark,  Delaware,  19718
United States
Recruiting Christine  Babenko 302-733-4549

UC San Diego Medical Center *Recruiting*
San Diego,  California,  92103
United States
Recruiting Beth  Romeril 619-543-6173

Denver Health Medical Center *Recruiting*
Denver,  Colorado,  80204
United States
Recruiting Jeffrey  Long 303-436-7906

Wishard Memorial Hospital *Recruiting*
Indianapolis,  Indiana,  46202
United States
Recruiting Gretchen  Huffman 317-287-3029

University of Tennessee-Memphis *Recruiting*
Memphis,  Tennessee,  38163
United States
Recruiting Stephanie  Panzer 901-448-5714


Additional Information:
Study ID Numbers:
  RTBSE-11-(N); 
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076648

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

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