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

Phase 3 Unknown Northfield Laboratories

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: —
Primary completion: —
Completion: —

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Polymerized Human Hemoglobin (Pyridoxylated)	Protein / enzyme biologic	6 unknown	—

Indications

No indication recorded.