Evidence map›Paper›PMID 35101083›Full record

ArticleTrials2022

Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery.

Maura Marcucci, Thomas W Painter, David Conen, Kate Leslie, Vladimir V Lomivorotov, Daniel Sessler, Matthew T V Chan, Flavia K Borges, Maria J Martínez Zapata, C Y Wang and 58 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
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. It is linked to trial NCT03505723 (PeriOperative ISchemic Evaluation-3 Trial), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
4.3field-weighted citation impact, top 5% 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.

NCT03505723 phase3completednot on this map

PeriOperative ISchemic Evaluation-3 Trial

TypeinterventionalSponsorPopulation Health Research InstituteRan2018 to 2023Enrolled9,535ConditionsPerioperative Bleeding, Venous Thrombosis, Arterial ThrombosisArmsTranexamic Acid, Placebo (Saline), Perioperative hypotension-avoidance strategy, Perioperative hypertension-avoidance strategy
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 26 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Observational
  7. Review
  8. Article
  9. Prehospital tranexamic acid for trauma victims.Journal of intensive care · 2023
    Review
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

68 authors at 20 institutions in 22 countries.

Maura MarcucciDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada. marcum2@mcmaster.ca.ORCID http://orcid.org/0000-0002-8468-7991
Thomas W PainterDiscipline of Acute Care Medicine, University of Adelaide, Adelaide, South Australia, Australia.
David ConenDepartment of Medicine, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Kate LeslieDepartment of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Australia.
Vladimir V LomivorotovDepartment of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia.
Daniel SesslerDepartment of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Matthew T V ChanThe Chinese University of Hong Kong, Hong Kong, China.
Flavia K BorgesDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Maria J Martínez ZapataIberoamerican Cochrane Centre-Public Health and Clinical Epidemiology Service, IIB Sant Pau, CIBER de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.
C Y WangDepartment of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Denis XavierSt. John's Medical College, Bangalore, India.
Sandra N OforiDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Giovanni LandoniDepartment of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Sergey EfremovSaint Petersburg State University Hospital, Saint Petersburg, Russia.
Ydo V KleinlugtenbeltDepartment of Orthopedic and Trauma Surgery, Deventer Ziekenhuis, Deventer, the Netherlands.
Wojciech SzczeklikJagiellonian University Medical College, Center for Intensive Care and Perioperative Medicine, Krakow, Poland.
Denis SchmartzCHU Brugmann, Université libre de Bruxelles, Brussels, Belgium.
Amit X GargPopulation Health Research Institute, Hamilton, ON, Canada.
Timothy G ShortAuckland City Hospital, Auckland, New Zealand.
Maria WittmannDepartment of Anesthesiology, University Hospital, Bonn, Germany.
Christian S MeyhoffDepartment of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.
Mohammed AmirShifa International Hospital (STMU), Islamabad, Pakistan.
David TorresClinica Santa Maria, Santiago, Chile.
Ameen PatelDepartment of Medicine, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Emmanuelle DuceppePopulation Health Research Institute, Hamilton, ON, Canada.
Kurtz RuetzlerDepartment of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Joel L ParlowDepartment of Anesthesiology and Perioperative Medicine, Kingston General Hospital and Queen's University, Kingston, ON, Canada.
Vikas TandonDepartment of Medicine, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Michael K WangDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Edith FleischmannDepartment of Anesthesia, General Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria.
Carisi A PolanczykUniversidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
Raja JayaramNuffield Department of Anaesthetics, Clinical Neurosciences, University of Oxford, Oxford, UK.
Sergey V AstrakovCity hospital No. 25, Novosibirsk, Russia.
Mangala RaoSt. John's Medical College, Bangalore, India.
Tomas VanHelderDepartment of Anesthesia, McMaster University, Hamilton, ON, Canada.
William K K WuThe Chinese University of Hong Kong, Hong Kong, China.
Chao Chia CheongDepartment of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Sabry AyadCase Western Reserve University, Anesthesiology Institute, Cleveland Clinic - Fairview Hospital, Cleveland, OH, USA.
Marat AbubakirovMeshalkin National Medical Research Center, Novosibirsk, Russia.
Mikhail KirovDepartment of Anesthesiology and Intensive Care Medicine, Northern State Medical University, Arkhangelsk, Russia.
Keyur BhattSIDS Hospital & Research Centre, Surat, India.
Miriam de NadalAnesthesiology and Intensive Care Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Valery LikhvantsevV. Negovskiy Reanimatology Research Institute, Moscow, Russia.
Pilar Paniagua IglesisasDepartment of Anaesthesia and Pain Management Santa Creu i Sant Pau University Hospital, Barcelona, Spain.
Hector J AguadoTrauma & Orthopaedic surgery department, Hospital Clínico Universitario, Valladolid, Spain.
Michael McGillionPopulation Health Research Institute, Hamilton, ON, Canada.
Andre LamyPopulation Health Research Institute, Hamilton, ON, Canada.
Richard P WhitlockPopulation Health Research Institute, Hamilton, ON, Canada.
Pavel RoshanovDepartment of Medicine, London Health Sciences Centre, London, ON, Canada.
David StilloPopulation Health Research Institute, Hamilton, ON, Canada.
Ingrid CoplandPopulation Health Research Institute, Hamilton, ON, Canada.
Jessica VincentPopulation Health Research Institute, Hamilton, ON, Canada.
Kumar BalasubramanianPopulation Health Research Institute, Hamilton, ON, Canada.
Shrikant I BangdiwalaDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Bruce BiccardDepartment of Anaesthesia and Perioperative Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa.
Andrea KurzDepartment of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Sadeesh SrinathanDepartment of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.
Shirley PetitPopulation Health Research Institute, Hamilton, ON, Canada.
John EikelboomDepartment of Medicine, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Toby RichardsFaculty of Health and Medical Sciences, University of Western Australia, Perth, Australia.
Peter L GrossDepartment of Medicine, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Pascal AlfonsiDepartment of Anesthesiology, GH Paris Saint Joseph, Paris, France.
Gordon GuyattDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Emily Belley-CoteDepartment of Medicine, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Jessica SpenceDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
William McIntyreDepartment of Medicine, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Salim YusufDepartment of Medicine, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
P J DevereauxDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 237 Barton Street East, Hamilton, ON, L8L 2X2, Canada.
Population Health Research Institute · CACleveland Clinic · USMcMaster University · CAChinese University of Hong Kong · HKNovosibirsk State University · RUSt.John's Medical College Hospital · INUniversity of Malaya · MYBodyline Hospitals · INCentre Hospitalier Universitaire Brugmann · BEDeventer Ziekenhuis · NLHôpital Paris Saint-Joseph · FRHospital Clínico Universitario de Valladolid · ESHospital de Sant Pau · ESIberoamerican Cochrane Centre · ESImpact · CAJagiellonian University · PLLondon Health Sciences Centre · CAMedical University of Vienna · ATMeshalkin National Medical Research Center · RUNorthern State Medical University · RU

Funding

CIHR FDN-143302National Health and Medical Research Council, Australia 1162362Research Grant Council, Hong Kong SAR 14104419
6 · The paper itself

Abstract

backgroundFor patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes.

methodsThe PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients ≥45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on ≥ 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the target mean arterial pressure during surgery. Outcome adjudicators are blinded to the blood pressure treatment allocation. Patients are followed up at 30 days and 1 year after randomization. DISCUSSION: Bleeding and hypotension in noncardiac surgery are common and have a substantial impact on patient prognosis. The POISE-3 trial will evaluate two interventions to determine their impact on bleeding, cardiovascular complications, and mortality.

trial registrationClinicalTrials.gov NCT03505723. Registered on 23 April 2018.

Indexed as

Antifibrinolytic AgentsHypotensionTranexamic AcidBlood Loss, SurgicalHumansPerioperative CareRandomized Controlled Trials as TopicAntifibrinolytic AgentsTranexamic AcidCardiovascular complicationsNoncardiac surgeryPerioperative bleedingPerioperative hypotensionRandomized controlled trialTranexamic acid

Identifiers

PMID35101083
PMCPMC8805242
OpenAlexW4210420077

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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.