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

NCT ID: NCT00076648

Last Updated: 2006-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Hemorrhagic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Poly SFH-P Injection

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northfield Laboratories

INDUSTRY

Sponsor Role lead

Locations

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Scripps Mercy

San Diego, California, United States

Site Status

UC San Diego Medical Center

San Diego, California, United States

Site Status

Denver Health Medical Center

Denver, Colorado, United States

Site Status

Christiana Hospital

Newark, Delaware, United States

Site Status

Medical Center of Central Georgia

Macon, Georgia, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Methodist Hospital of Indiana

Indianapolis, Indiana, United States

Site Status

Wishard Memorial Hospital

Indianapolis, Indiana, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of Kentucky Medical Center

Lexington, Kentucky, United States

Site Status

Detroit Receiving Hospital

Detroit, Michigan, United States

Site Status

Sinai Grace Hospital

Detroit, Michigan, United States

Site Status

The Mayo Clinic

Rochester, Minnesota, United States

Site Status

Albany Medical Center

Albany, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Site Status

St. Luke's Regional Resource Trauma Center

Bethlehem, Pennsylvania, United States

Site Status

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Johnson City Medical Center

Johnson City, Tennessee, United States

Site Status

University of Tennessee-Memphis

Memphis, Tennessee, United States

Site Status

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status

Memorial-Hermann Hospital

Houston, Texas, United States

Site Status

University of Texas Health Science Center

San Antonio, Texas, United States

Site Status

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status

Sentara Norfolk Hospital

Norfolk, Virginia, United States

Site Status

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Site Status

West Virginia University/Jon Michael Moore Trauma Center

Morgantown, West Virginia, United States

Site Status

Countries

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United States

References

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Moore EE, Moore FA, Fabian TC, Bernard AC, Fulda GJ, Hoyt DB, Duane TM, Weireter LJ Jr, Gomez GA, Cipolle MD, Rodman GH Jr, Malangoni MA, Hides GA, Omert LA, Gould SA; PolyHeme Study Group. Human polymerized hemoglobin for the treatment of hemorrhagic shock when blood is unavailable: the USA multicenter trial. J Am Coll Surg. 2009 Jan;208(1):1-13. doi: 10.1016/j.jamcollsurg.2008.09.023. Epub 2008 Nov 7.

Reference Type DERIVED
PMID: 19228496 (View on PubMed)

Other Identifiers

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RTBSE-11-(N)

Identifier Type: -

Identifier Source: org_study_id