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

Trials. 2015 Jul 30;16:321. doi: 10.1186/s13063-015-0844-5.

Abstract

Background: Severe traumatic injury and haemorrhagic shock are frequently associated with disruptions of coagulation function (such as trauma-induced coagulopathy 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 haemorrhaging patients may correct TIC, minimise inflammation, 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 patients with major traumatic haemorrhage.

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 trauma patients. Two hundred and ten eligible adult trauma patients 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 include coagulation 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 haemorrhagic shock in both civilian and military populations.

Trial registration: ClinicalTrials.gov: NCT02303964 on 28 November 2014.

Trial registration: ClinicalTrials.gov NCT01818427 NCT01838863 NCT02303964.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Biomarkers / blood
  • Blood Coagulation
  • Blood Component Transfusion / adverse effects
  • Blood Component Transfusion / methods*
  • Blood Component Transfusion / mortality
  • Blood Volume
  • Clinical Protocols
  • Emergency Medical Services / methods*
  • Fluid Therapy
  • Humans
  • Inflammation Mediators / blood
  • Injury Severity Score
  • Intention to Treat Analysis
  • Length of Stay
  • Plasma*
  • Prospective Studies
  • Research Design
  • Shock, Hemorrhagic / blood
  • Shock, Hemorrhagic / diagnosis
  • Shock, Hemorrhagic / mortality
  • Shock, Hemorrhagic / physiopathology
  • Shock, Hemorrhagic / therapy*
  • Time Factors
  • Treatment Outcome
  • United States
  • United States Department of Defense
  • Wounds and Injuries / blood
  • Wounds and Injuries / diagnosis
  • Wounds and Injuries / mortality
  • Wounds and Injuries / physiopathology
  • Wounds and Injuries / therapy*

Substances

  • Biomarkers
  • Inflammation Mediators

Associated data

  • ClinicalTrials.gov/NCT01818427
  • ClinicalTrials.gov/NCT01838863
  • ClinicalTrials.gov/NCT02303964