Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076648
Status:
UNKNOWN
Last Update Posted:
2006-08-02
First Post:
2004-01-28
Brief Title:
Safety and Efficacy of PolyHemeR in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting
Sponsor:
Northfield Laboratories
Organization:
Northfield Laboratories
Study Overview
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 PolyHemeR When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting
Status:
UNKNOWN
Status Verified Date:
2006-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None