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

July 31, 2006 updated by: Northfield Laboratories

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • UC San Diego Medical Center
      • San Diego, California, United States, 92103
        • Scripps Mercy
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Hospital
    • Georgia
      • Macon, Georgia, United States, 31201
        • Medical Center of Central Georgia
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Methodist Hospital of Indiana
      • Indianapolis, Indiana, United States, 46202
        • Wishard Memorial Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Detroit Receiving Hospital
      • Detroit, Michigan, United States, 48201
        • Sinai Grace Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • The Mayo Clinic
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0769
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Regional Resource Trauma Center
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • Johnson City Medical Center
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee-Memphis
    • Texas
      • Fort Sam, Houston, Texas, United States, 78234-6315
        • Brooke Army Medical Center
      • Houston, Texas, United States, 77030
        • Memorial-Hermann Hospital
      • San Antonio, Texas, United States, 78284
        • University of Texas Health Science Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health Sciences Center
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Virginia
      • Falls Church, Virginia, United States, 22066
        • Inova Fairfax Hospital
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk Hospital
      • Richmond, Virginia, United States, 23298-0454
        • Virginia Commonwealth University Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University/Jon Michael Moore Trauma Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northfield Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 28, 2004

First Submitted That Met QC Criteria

January 29, 2004

First Posted (ESTIMATE)

January 30, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2006

Last Update Submitted That Met QC Criteria

July 31, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTBSE-11-(N)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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