Evidence map›Paper›PMID 26220293›Full record

Trial reportTrials2015

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

Penny S Reynolds, Mary Jane Michael, Emily D Cochran, Jacob A Wegelin, Bruce D Spiess

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02303964 (Pre-Hospital Use of Plasma for Traumatic Hemorrhage), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02303964 phase2 / phase3withdrawnnot on this map

Pre-Hospital Use of Plasma for Traumatic Hemorrhage

TypeinterventionalSponsorVirginia Commonwealth UniversityRan2014 to 2016Enrolled0ConditionsShock, HemorrhagicArmsPlasma, Normal saline
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Blood transfusion strategies for major bleeding in trauma.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Penny S ReynoldsDepartment of Anesthesiology, Virginia Commonwealth University Medical Center, Richmond, VA, USA. psreynolds@vcu.edu.
Mary Jane MichaelDepartment of Anesthesiology, Virginia Commonwealth University Medical Center, Richmond, VA, USA. mmichael@vcu.edu.
Emily D CochranDepartment of Anesthesiology, Virginia Commonwealth University Medical Center, Richmond, VA, USA. edcochran@vcu.edu.
Jacob A WegelinDepartment of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA. jacobwegelin@fastmail.fm.
Bruce D SpiessDepartment of Anesthesiology, Virginia Commonwealth University Medical Center, Richmond, VA, USA. bdspiess@hsc.vcu.edu.
Virginia Commonwealth University Medical Center · USVirginia Commonwealth University · US

Funding

Center for Clinical and Translational ResearchUL1TR000058 · NCATS · VIRGINIA COMMONWEALTH UNIVERSITY · PI MOELLER, FREDERICK GERARD · 2012 to 2015
$12.5M
NCATS NIH HHS UL1 TR000058NCATS NIH HHS UL1TR000058
6 · The paper itself

Abstract

backgroundSevere 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/

designThis 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 registrationClinicalTrials.gov: NCT02303964 on 28 November 2014.

Indexed as

PlasmaBiomarkersBlood CoagulationBlood Component TransfusionBlood VolumeClinical ProtocolsEmergency Medical ServicesFluid TherapyHumansInflammation MediatorsInjury Severity ScoreIntention to Treat AnalysisLength of StayProspective StudiesResearch DesignShock, HemorrhagicBiomarkersInflammation Mediators

Identifiers

PMID26220293
PMCPMC4518517
OpenAlexW1949165355

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.