Evidence map›Paper›PMID 32699643›Full record

ArticlePilot and feasibility studies2020

Tranexamic acid and rosuvastatin in patients at risk of cardiovascular events after noncardiac surgery: a pilot of the POISE-3 randomized controlled trial.

Maura Marcucci, Emmanuelle Duceppe, Yannick Le Manach, Clive Kearon, John W Eikelboom, Kayla Pohl, Jessica Vincent, Saeed Darvish-Kazem, Sadeesh K Srinathan, John D D Neary and 7 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
3.4field-weighted citation impact, top 6% 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

2 citing papers in PubMed, 24 citations in OpenAlex.

  1. Review
  2. 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

17 authors at 9 institutions in 2 countries.

Maura MarcucciDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON Canada.ORCID 0000-0002-8468-7991
Emmanuelle DuceppeDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON Canada.
Yannick Le ManachDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON Canada.
Clive KearonDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON Canada.
John W EikelboomDepartment of Medicine, McMaster University, Hamilton, ON Canada.
Kayla PohlPopulation Health Research Institute, Hamilton, ON Canada.
Jessica VincentPopulation Health Research Institute, Hamilton, ON Canada.
Saeed Darvish-KazemDepartment of Medicine, McMaster University, Hamilton, ON Canada.
Sadeesh K SrinathanDepartment of Surgery, University of Manitoba, Winnipeg, MB Canada.
John D D NearyDepartment of Medicine, McMaster University, Hamilton, ON Canada.
Joel L ParlowDepartment of Anesthesiology and Perioperative Medicine, Kingston General Hospital and Queen's University, Kingston, ON Canada.
Andrea KurzDepartment of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH USA.
Peter L GrossDepartment of Medicine, University of Montreal, Montreal, QC Canada.
Marko MrkobradaDepartment of Medicine, University of Western Ontario, London, ON Canada.
Kumar BalasubramanianPopulation Health Research Institute, Hamilton, ON Canada.
Daniel I SesslerDepartment of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH USA.
P J DevereauxDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON Canada.
Population Health Research Institute · CACleveland Clinic · USMcMaster University · CAImpact · CAQueen's University · CAUniversité de Montréal · CAUniversity of Manitoba · CAWestern University · CAWilliam Osler Health System · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSurgical bleeding is associated with postoperative cardiovascular complications. The efficacy and safety of tranexamic acid (TXA) in noncardiac surgery are still uncertain. Statins may prevent perioperative cardiovascular complications. We conducted a pilot to assess the feasibility of a perioperative trial of TXA and rosuvastatin.

methodsUsing a factorial design, we randomized patients at cardiovascular risk undergoing noncardiac surgery to intravenous TXA (1 g at the start and end of surgery) or placebo, and oral rosuvastatin (40 mg before and 20 mg daily for 30 days after surgery) or placebo. Feasibility outcomes included recruitment rates, follow-up, and compliance to interventions. Clinical outcomes were secondarily explored.

resultsAfter 3 months, we changed the design to a partial factorial due to the difficult recruitment of statin-naive patients. Over 6 months, 100 patients were randomized in the TXA trial (49 TXA, 51 placebo), 34 in the rosuvastatin trial (18 rosuvastatin, 16 placebo). Ninety-two percent (95% CI 80-98) of TXA and 86% (95% CI 74-94) of TXA-placebo patients received the 2 study doses. Thirty-three percent (95% CI 13-59) of rosuvastatin patients and 37% (95% CI 15-65) of rosuvastatin-placebo patients discontinued the study drug. A major cardiovascular complication occurred at 30 days in 1 TXA and 6 TXA-placebo patients, and 1 rosuvastatin and no rosuvastatin-placebo patients.

conclusionsOur pilot study supports the feasibility of a perioperative TXA trial in noncardiac surgery. Feasibility of a perioperative rosuvastatin trial is uncertain because of a high prevalence of statin use in the target population and concerns about compliance.

trial registrationClinicalTrials.govNCT02546648.

Indexed as

FeasibilityNoncardiac surgeryPilotRosuvastatinTranexamic acid

Identifiers

PMID32699643
PMCPMC7372857
OpenAlexW3044847111

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.