Evidence map›Paper›PMID 34429127›Full record

Trial reportTrials2021

CRISTAL (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): statistical analysis plan.

Verinder Singh Sidhu, Thu-Lan Kelly, Nicole Pratt, Steven Graves, Rachelle Buchbinder, Justine Naylor, Richard de Steiger, Ilana Ackerman, Sam Adie, Michelle Lorimer and 3 more

Abstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
–field-weighted citation impact
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

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

  1. Antiplatelet agents for the treatment of deep venous thrombosis.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  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

13 authors.

Verinder Singh SidhuWhitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, South West Sydney Clinical School, The University of New South Wales Sydney, Sydney, NSW, Australia. Verinder.s.sidhu@gmail.com.ORCID http://orcid.org/0000-0001-6511-1383
Thu-Lan KellyClinical and Health Sciences, Quality Use of Medicines Pharmacy Research Centre, University of South Australia, Adelaide, Australia.
Nicole PrattClinical and Health Sciences, Quality Use of Medicines Pharmacy Research Centre, University of South Australia, Adelaide, Australia.
Steven GravesAustralian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.
Rachelle BuchbinderDepartment of Epidemiology and Preventive Medicine, School of Public Health & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Justine NaylorWhitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, South West Sydney Clinical School, The University of New South Wales Sydney, Sydney, NSW, Australia.
Richard de SteigerDepartment of Surgery, Epworth Healthcare, University of Melbourne, Melbourne, Victoria, Australia.
Ilana AckermanDepartment of Epidemiology and Preventive Medicine, School of Public Health & Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Sam AdieSt. George and Sutherland Clinical School, The University of New South Wales Sydney, Sydney, NSW, Australia.
Michelle LorimerSouth Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
Durga BastirasAustralian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.
Kara CashmanSouth Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
Ian HarrisWhitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, South West Sydney Clinical School, The University of New South Wales Sydney, Sydney, NSW, Australia.

Funding

Department of Health, Australian Government 1152285
6 · The paper itself

Abstract

backgroundThis a priori statistical analysis plan describes the analysis for CRISTAL.

methodsCRISTAL (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) aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic venous thromboembolism (VTE) following hip arthroplasty (HA) or knee arthroplasty (KA). The study is nested within the Australian Orthopaedic Association National Joint Replacement Registry. The trial was commenced in April 2019 and after an unplanned interim analysis, recruitment was stopped (December 2020), as the stopping rule was met for the primary outcome. The clusters comprised hospitals performing > 250 HA and/or KA procedures per annum, whereby all adults (> 18 years) undergoing HA or KA were recruited. Each hospital was randomised to commence with aspirin, orally, 85-150 mg daily or LMWH (enoxaparin), 40 mg, subcutaneously, daily within 24 h postoperatively, for 35 days after HA and 14 days after KA. Crossover was planned once the registration target was met for the first arm. The primary end point is symptomatic VTE within 90 days. Secondary outcomes include readmission, reoperation, major bleeding and death within 90 days, and reoperation and patient-reported pain, function and health status at 6 months. The main analyses will focus on the primary and secondary outcomes for patients undergoing elective primary total HA and KA for osteoarthritis. The analysis will use an intention-to-treat approach with cluster summary methods to compare treatment arms. As the trial stopped early, analyses will account for incomplete cluster crossover and unequal cluster sizes.

conclusionsThis paper provides a detailed statistical analysis plan for CRISTAL.

trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12618001879257 . Registered on 19/11/2018.

Indexed as

Arthroplasty, Replacement, KneeVenous ThromboembolismAdultAspirinAustraliaHeparin, Low-Molecular-WeightHumansRegistriesAspirinHeparin, Low-Molecular-WeightAspirinHip arthroplastyKnee arthroplastyLow molecular weight heparinStatistical analysis planVenous thromboembolism

Identifiers

PMID34429127
PMCPMC8383378

What OpenQuestion holds

Textmetadata
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.