Prehospital use of plasma in XXXX (The PUPTH Trial): study protocol for a randomised controlled trial.

@entity1 @entity32 @entity548 @entity1003 @entity3459 @entity130
BACKGROUND: Severe @entity130 and @entity548 are frequently associated with disruptions of coagulation function (such as @entity130 -induced @entity1003 TIC) and activation of inflammatory cascades. These pathologies may be exacerbated by current standard of care resuscitation protocols. Observational studies suggest early administration of plasma to severely-injured @entity548 @entity1 may correct TIC, minimise @entity32 , and improve survival. The proposed randomised clinical trial will evaluate the clinical effectiveness of pre-hospital plasma administration compared with standard- of-care crystalloid resuscitation in severely-injured @entity1 with major traumatic @entity548 . METHODS/DESIGN: This 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 @entity130 @entity1 . Two hundred and ten eligible adult @entity130 @entity1 will be randomised to receive either two units of plasma, to be 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 @entity3459 and lipidomic/pro-inflammatory marker responses, volume of resuscitation fluids (crystalloid, colloid) and blood products administered, and major hospital outcomes (e.g. incidence of MSOF, length of ICU stay, length of hospital stay). DISCUSSION: This study is part of a US Department of Defense (DoD)-funded multi-institutional investigation, conducted independently of, but in parallel with, the University of Pittsburgh and University of Denver. 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 @entity548 in both civilian and military populations. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02303964 on 28 November 2014.
