Evidence map›Paper›PMID 31699735›Full record

ArticleBMJ open2019

CRISTAL: protocol for a cluster randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study.

Verinder Singh Sidhu, Steven E Graves, Rachelle Buchbinder, Justine Maree Naylor, Nicole L Pratt, Richard S de Steiger, Beng H Chong, Ilana N Ackerman, Sam Adie, Anthony Harris and 10 more

Erratum issuedOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 8% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Antiplatelet agents for the treatment of deep venous thrombosis.The Cochrane database of systematic reviews · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 11 institutions in 1 country.

Verinder Singh SidhuCRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia verinder.s.sidhu@gmail.com.ORCID 0000-0001-6511-1383
Steven E GravesAustralian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.
Rachelle BuchbinderDepartment of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Justine Maree NaylorCRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.
Nicole L PrattSchool of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia, Australia.
Richard S de SteigerDepartment of Surgery, Epworth Healthcare, University of Melbourne, Melbourne, Victoria, Australia.
Beng H ChongDepartment of Haematology, Saint George and Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Ilana N AckermanDepartment of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.ORCID 0000-0002-6028-1612
Sam AdieFaculty of Medicine, Saint George and Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Anthony HarrisMonash University Centre for Health Economics, Caufield, Victoria, Australia.
Amber HansenCRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.
Maggie CrippsCRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.
Michelle LorimerSouth Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
Steve WebbDepartment of Intensive Care, St John of God Hospital, Subiaco, Western Australia, Australia.
Ornella ClavisiMusculoskeletal Australia, Melbourne, Victoria, Australia.
Elizabeth C GriffithSouth Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
Durga AnandanAustralian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.
Grace O'DonohueAustralian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.
Thu-Lan KellySchool of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia, Australia.
Ian A HarrisCRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.
UNSW Sydney · AUAustralian Orthopaedic Association · AUMonash University · AUSouth Australian Health and Medical Research Institute · AUSutherland Hospital · AUUniversity of South Australia · AUAustralian Institute for Musculoskeletal Science · AUCabrini Hospital · AUSt John of God Subiaco Hospital · AUThe University of Melbourne · AUThe University of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionVenous thromboembolism (VTE) is a serious complication following hip arthroplasty (HA) and knee arthroplasty (KA). This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA. METHODS AND ANALYSIS: This is a cluster randomised, crossover, non-inferiority, trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will consist of Australian hospitals performing at least 250 HA and/or KA procedures per annum. All adult patients undergoing HA or KA will be included. The intervention will be aspirin, orally, 85-150 mg daily. The comparator will be LMWH (enoxaparin) 40 mg, subcutaneously, daily. Both drugs will commence within 24 hours postoperatively and continue for 35 days after HA and 14 days after KA. Each hospital will be randomised to commence with aspirin or LMWH and then crossover to the alternative treatment after meeting the recruitment target. Data will be collected through the AOANJRR via patient-reported surveys. The primary outcome is symptomatic VTE within 90 days post surgery, verified by AOANJRR staff. The primary analysis will include only patients undergoing elective primary total hip arthroplasty and total knee arthroplasty for osteoarthritis. Secondary outcomes will include symptomatic VTE for all HA and KA (including partial and revision) within 90 days, readmission, reoperation, major bleeding and death within 90 days and reoperation, death and patient-reported pain, function and health status at 6 months. If aspirin is found to be inferior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 15 562 patients from 31 hospitals. ETHICS AND DISSEMINATION: Ethics approval has been granted. Trial results will be submitted for publication. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001879257, pre-results) and is endorsed by the Australia and New Zealand Musculoskeletal Clinical Trials Network.

Indexed as

Arthroplasty, Replacement, HipArthroplasty, Replacement, KneeAspirinAustraliaCross-Over StudiesEquivalence Trials as TopicFibrinolytic AgentsHeparin, Low-Molecular-WeightHumansPostoperative ComplicationsRandomized Controlled Trials as TopicRegistriesVenous ThromboembolismAspirinFibrinolytic AgentsHeparin, Low-Molecular-Weightaspirindeep venous thrombosiship arthroplastyknee arthroplastylow molecular weight heparinvenous thromboembolism

Identifiers

PMID31699735
PMCPMC6858170
OpenAlexW2983663591

What OpenQuestion holds

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LicenceCC BY-NC
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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.