Evidence map›Paper›PMID 35550642›Full record

ArticleTrials2022

The effectiveness and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma patients with uncontrolled torso haemorrhage: study protocol for a randomised clinical trial (the UK-REBOA trial).

Jan O Jansen, Claire Cochran, Dwayne Boyers, Katie Gillies, Robbie Lendrum, Sam Sadek, Fiona Lecky, Graeme MacLennan, Marion K Campbell, UK-REBOA Trial grantholders

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
3.6field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

10 authors at 4 institutions in 2 countries.

Jan O JansenHealth Services Research Unit, University of Aberdeen, Aberdeen, UK. jjansen@uabmc.edu.ORCID http://orcid.org/0000-0001-8863-4398
Claire CochranHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Dwayne BoyersHealth Economics Research Unit, University of Aberdeen, Aberdeen, UK.
Katie GilliesHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Robbie LendrumBarts Health NHS Trust, Royal London Hospital, St. Bartholomew's Hospital, London, UK.
Sam SadekBarts Health NHS Trust, Royal London Hospital, St. Bartholomew's Hospital, London, UK.
Fiona LeckyCentre for Urgent and Emergency Care Research, Health Services Research Section, School of Health and Related Research, University of Sheffield, Sheffield, UK.
Graeme MacLennanHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Marion K CampbellHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
UK-REBOA Trial grantholders
University of Aberdeen · GBSt Bartholomew's Hospital · GBUniversity of Sheffield · GBUniversity of Alabama at Birmingham · US

Funding

Chief Scientist Office HERU1Chief Scientist Office HSRU1
6 · The paper itself

Abstract

backgroundHaemorrhage is the most common cause of preventable death after injury. REBOA is a novel technique whereby a percutaneously inserted balloon is deployed in the aorta, providing a relatively quick means of temporarily controlling haemorrhage and augmenting cerebral and coronary perfusion, until definitive control of haemorrhage can be attained. The aim of the UK-REBOA trial is to establish the clinical and cost-effectiveness of a policy of standard major trauma centre treatment plus REBOA, as compared with standard major trauma centre treatment alone, for the management of uncontrolled torso haemorrhage caused by injury.

methodsPragmatic, Bayesian, group-sequential, randomised controlled trial, performed in 16 major trauma centres in England. We aim to randomise 120 injured patients with suspected exsanguinating haemorrhage to either standard major trauma centre care plus REBOA or standard major trauma centre care alone. The primary clinical outcome is 90-day mortality. Secondary clinical outcomes include 3-h, 6-h, and 24-h mortality; in-hospital mortality; 6-month mortality; length of stay (in hospital and intensive care unit); 24-h blood product use; need for haemorrhage control procedure (operation or angioembolisation); and time to commencement of haemorrhage control procedure (REBOA, operation, or angioembolisation). The primary economic outcome is lifetime incremental cost per QALY gained, from a health and personal social services perspective. DISCUSSION: This study, which is the first to randomly allocate patients to treatment with REBOA or standard care, will contribute high-level evidence on the clinical and cost-effectiveness of REBOA in the management of trauma patients with exsanguinating haemorrhage and will provide important data on the feasibility of implementation of REBOA into mainstream clinical practice.

trial registrationISRCTN16184981.

Indexed as

Balloon OcclusionHemorrhageAortaBayes TheoremCost-Benefit AnalysisEndovascular ProceduresExsanguinationHumansPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicResuscitationTorsoUnited KingdomInjuryREBOAResuscitationResuscitative endovascular balloon occlusion of the aortaTrauma

Identifiers

PMID35550642
PMCPMC9097076
OpenAlexW4280596524

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.