Prehospital Use of Plasma for Traumatic Hemorrhage
Technical Report,01 Jun 2014,31 May 2015
Virginia Commonwealth University Richmond United States
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Pre-Hospital Use of Plasma for Traumatic Hemorrhage PUPTH is a prospective, randomized, open-label, non-blinded trial to determine the effect of pre-hospital administration of thawed plasma TP on mortality, morbidity, transfusion requirements, coagulation, and inflammatory response in severely-injured bleeding trauma patients. Two hundred and ten eligible adult trauma patients will be randomized to receive either two units of plasma, to administered in-field , vs standard of care normal saline NS. Main analyses will compare subjects allocated to TP to those allocated to NS on an intention-to-treat basis. Primary outcome measure is all cause 30 day mortality. Secondary outcome measures include coagulation and lipidomic pro-inflammatory marker responses, volume of resuscitation fluids and blood products administered, and major hospital outcomes. Demonstration of significant reductions in mortality and coagulopathic inflammatory related morbidities as a result of pre-hospital plasma administration would be of considerable clinical importance for the management of haemorrhagic shock in both civilian and military populations.