Evidence map›Paper›PMID 41453781›Full record

ArticleBMJ open2025

Prophylaxis for venous thromboembolism in traumatic brain injury: protocol for a randomised controlled trial.

Farhad Pirouzmand, Francois Mathieu, Alireza Mansouri, Kanthi Kavikondala, Ryan Alkins, J Gordon Boyd, Sean Christie, Philippe Couillard, Michael D Cusimano, Paul T Engels and 32 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03559114 (PROTEST Trial - PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury, a Double-blind Randomized Controlled Trial), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT03559114 phase3recruitingnot on this map

PROTEST Trial - PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury, a Double-blind Randomized Controlled Trial

TypeinterventionalSponsorSunnybrook Health Sciences CentreRan2018 to 2027Enrolled1,100ConditionsTraumatic Brain InjuryArmsDalteparin, Saline
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

42 authors.

Farhad PirouzmandDivision of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
Francois MathieuInterdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada.
Alireza MansouriNeurosurgery, Penn State Cancer Institute, Hershey, Pennsylvania, USA.ORCID http://orcid.org/0000-0002-7442-7539
Kanthi KavikondalaThe Centre for Clinical Trial Support, Sunnybrook Research Institute, Toronto, Ontario, Canada.
Ryan AlkinsDivision of Neurosurgery, Department of Surgery, Queen's University, Kingston, Ontario, Canada.
J Gordon BoydDepartment of Critical Care Medicine, Queen's University, Kingston, Ontario, Canada.
Sean ChristieNeurosurgery, Dalhousie University, Halifax, Nova Scotia, Canada.
Philippe CouillardDepartment of Critical Care Medicine, University of Calgary, Calgary, Alberta, Canada.
Michael D CusimanoDivision of Neurosurgery, Department of Surgery, Unity Health Toronto, Toronto, Ontario, Canada.
Paul T EngelsSurgery, McMaster University, Hamilton, Ontario, Canada.
Shane EnglishClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Daryl FourneyDivision of Neurosurgery, Department of Surgery, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
Robert FowlerInterdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada.
William GeertsDepartment of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Peter A GooderhamDivision of Neurosurgery, Department of Surgery, Vancouver General Hospital, Vancouver, British Columbia, Canada.
Donald GriesdaleCentre for Clinical Epidemiology & Evaluation, Vancouver Coastal Health Research Institute Clinical Research Unit, Vancouver, British Columbia, Canada.
Gary HunterNeurology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
Pejman Jabehdar MaralaniDepartment of Medical Imaging, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Michael E KellyDivision of Neurosurgery, Department of Surgery, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
Gail KleinCentre for Clinical Trial Support, Sunnybrook Research Institute, Toronto, Ontario, Canada.
Andreas H KramerDepartments of Critical Care Medicine, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.
Julie KrommDepartments of Critical Care Medicine, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.
Demetrios J KutsogiannisCritical Care Medicine, University of Alberta Faculty of Medicine and Dentistry, Edmonton, Alberta, Canada.
Francois LauzierPopulation Health and Optimal Health Practices Research Unit (Trauma-Emergency-Critical Care Medicine), Centre Hospitalier Universitaire de Québec-Université Laval, Québec City, Quebec, Canada.
Matylda MachnowskaDepartment of Medical Imaging, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
David M MasloveDepartment of Critical Care Medicine, Queen's University, Kingston, Ontario, Canada.
Jorge Mejia-MantillaFundación Valle del Lili, Cali, Colombia.
Rajiv MidhaDepartment of Clinical Neurosciences, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.
Basant MisraDepartment of Surgery, P D Hinduja National Hospital and Medical Research Centre, Mumbai, Maharashtra, India.
Laurel MurphyCritical Care, Dalhousie University, Halifax, Nova Scotia, Canada.
C J O'KellyDivision of Neurosurgery, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.
Chirag PatelDepartment of Medical Imaging, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Ruxandra L PintoInterdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada.
Antoine P PronovostInterdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada.
Mypinder SekhonCritical Care, The University of British Columbia - Vancouver Campus, Vancouver, British Columbia, Canada.
Sunjay V SharmaSurgery, McMaster University, Hamilton, Ontario, Canada.
John SinclairDivision of Neurosurgery, Department of Surgery, Ottawa Hospital, Ottawa, Ontario, Canada.
Eve TsaiDivision of Neurosurgery, University of Ottawa, Ottawa, Ontario, Canada.
Alexis F TurgeonPopulation Health and Optimal Health Practices Research Unit (Trauma-Emergency-Critical Care Medicine), Centre Hospitalier Universitaire de Québec-Université Laval, Québec City, Quebec, Canada.ORCID http://orcid.org/0000-0001-5675-8791
Abhijit WaradeDepartment of Surgery, P D Hinduja National Hospital and Medical Research Centre, Mumbai, Maharashtra, India.
Damon C ScalesInterdepartmental Division of Critical Care, University of Toronto, Toronto, Ontario, Canada damon.scales@sunnybrook.ca.ORCID http://orcid.org/0000-0001-7101-3958
PROTEST investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionVenous thromboembolism (VTE) is a common complication of traumatic brain injury (TBI) and is associated with increased morbidity and mortality. Low molecular weight heparin (LMWH) is recommended for prophylaxis against VTE after trauma but may increase the risk of progression of intracranial bleeding. Limited evidence exists to guide clinicians regarding the optimal timing of VTE prophylaxis in patients with acute TBI. This randomised controlled trial (RCT) will directly compare the safety and effectiveness of early versus delayed initiation of LMWH in patients with moderate to severe TBI. METHODS AND ANALYSIS: The study design is a Bayesian adaptive RCT comparing early (within three calendar days of injury) versus delayed (after study Day 7) VTE prophylaxis with the LMWH, dalteparin. All patients receive sequential compression devices until study Day 8. The co-primary effectiveness outcome is the development of clinically important VTE at study Day 8. The co-primary safety outcome is the development of clinically important intracranial bleeding at study Day 8. Secondary outcomes are mortality and functional outcomes (Glasgow Outcome Scale Extended and EQ-5D) measured at study Days 30 and 180; clinically diagnosed VTE to Day 30 and progression of intracranial bleeding to Day 8. ETHICS AND DISSEMINATION: This study has been approved through Clinical Trials Ontario's streamlined ethics review process (board of record, Sunnybrook Health Sciences Centre) and all participating centres. It is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and Health Canada regulatory requirements. We anticipate that the trial will achieve wide dissemination through publication in a peer-reviewed medical journal and presentation at international conferences targeting the fields of critical care, trauma and neurosurgery. The results of this trial will help guide clinicians aiming to balance the risks and benefits of early anticoagulant prophylaxis after TBI and will inform guideline development. TRIAL REGISTRATION NUMBER: NCT03559114.

Indexed as

AnticoagulantsBrain Injuries, TraumaticDalteparinVenous ThromboembolismBayes TheoremHeparin, Low-Molecular-WeightHumansIntracranial HemorrhagesRandomized Controlled Trials as TopicAnticoagulantsDalteparinHeparin, Low-Molecular-WeightAdult intensive & critical careAnticoagulationBrain InjuriesThromboembolismTRAUMA MANAGEMENT

Identifiers

PMID41453781
PMCPMC12742180

What OpenQuestion holds

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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.