Hemorrhagic Shock Clinical Trial
Official title:
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
| NCT number | NCT00076648 |
| Other study ID # | RTBSE-11-(N) |
| Secondary ID | |
| Status | Active, not recruiting |
| Phase | Phase 3 |
| First received | January 28, 2004 |
| Last updated | July 31, 2006 |
| Verified date | July 2006 |
| Source | Northfield Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Albany Medical Center | Albany | New York |
| United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
| United States | St. Luke's Regional Resource Trauma Center | Bethlehem | Pennsylvania |
| 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 | Denver Health Medical Center | Denver | Colorado |
| United States | Detroit Receiving Hospital | Detroit | Michigan |
| United States | Sinai Grace Hospital | Detroit | Michigan |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Inova Fairfax Hospital | Falls Church | Virginia |
| United States | Brooke Army Medical Center | Fort Sam, Houston | Texas |
| United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | Memorial-Hermann Hospital | Houston | Texas |
| United States | Methodist Hospital of Indiana | Indianapolis | Indiana |
| United States | Wishard Memorial Hospital | Indianapolis | Indiana |
| United States | Johnson City Medical Center | Johnson City | Tennessee |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | University of Kentucky Medical Center | Lexington | Kentucky |
| United States | Medical Center of Central Georgia | Macon | Georgia |
| United States | Loyola University Medical Center | Maywood | Illinois |
| United States | University of Tennessee-Memphis | Memphis | Tennessee |
| United States | West Virginia University/Jon Michael Moore Trauma Center | Morgantown | West Virginia |
| United States | Christiana Hospital | Newark | Delaware |
| United States | Sentara Norfolk Hospital | Norfolk | Virginia |
| United States | Virginia Commonwealth University Medical Center | Richmond | Virginia |
| United States | The Mayo Clinic | Rochester | Minnesota |
| United States | LDS Hospital | Salt Lake City | Utah |
| United States | University of Utah Health Sciences Center | Salt Lake City | Utah |
| United States | University of Texas Health Science Center | San Antonio | Texas |
| United States | Scripps Mercy | San Diego | California |
| United States | UC San Diego Medical Center | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| Northfield Laboratories |
United States,
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