Evidence map›Paper›PMID 42754280›Full record

ArticleBMJ open2026

Timing to restart direct oral anticoagulants after traumatic intracranial haemorrhage (RESTART tICrH): study protocol for a randomised controlled multicentre trial.

Ellie Edlmann, Siddarth Kannan, Laura Wright, Ben Hardwick, Michaela Brown, Matthew Gornall, Terence McLoughlin, Victoria Haunton, Yankier Pijeira Perez, Dyfrig A Hughes and 7 more

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

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06322953 (A Randomised Trial of Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage), 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.

NCT06322953 phase3recruitingnot on this map

A Randomised Trial of Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage

TypeinterventionalSponsorWalton Centre NHS Foundation TrustRan2025 to 2028Enrolled1,084ConditionsTraumatic Intracranial HaemorrhageArmsDirect-Acting Oral Anticoagulants (used as per local standard practice)
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

17 authors.

Ellie EdlmannDepartment of Neurosurgery, University of Plymouth, Plymouth, UK.
Siddarth KannanNeurosurgery, Walton Centre for Neurology and Neurosurgery, Liverpool, UK.ORCID http://orcid.org/0009-0004-8703-4859
Laura WrightLiverpool Clinical Trials Centre, Liverpool, UK.
Ben HardwickLiverpool Clinical Trials Centre, Liverpool, UK.
Michaela BrownLiverpool Clinical Trials Centre, Liverpool, UK.
Matthew GornallLiverpool Clinical Trials Centre, Liverpool, UK.
Terence McLoughlinEmergency Department, Royal Liverpool University Hospital, Liverpool, UK.
Victoria HauntonFaculty of Health, Plymouth University, Plymouth, UK.
Yankier Pijeira PerezCentre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.ORCID http://orcid.org/0000-0002-8816-9008
Dyfrig A HughesCentre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.ORCID http://orcid.org/0000-0001-8247-7459
Nic VinePublic and Patient Involvement representatives, London, UK.
Helen GranthamPublic and Patient Involvement representatives, London, UK.
Truman J MillingUniversity of Texas at Austin Dell Seton Medical Center, Austin, Texas, USA.
Deirdre A LaneDepartment of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.ORCID http://orcid.org/0000-0002-5604-9378
Gregory Y H LipLiverpool Centre for Cardiovascular Science, Liverpool John Moores University, Liverpool, UK.ORCID http://orcid.org/0000-0002-7566-1626
Michael D JenkinsonNeurosurgery, Walton Centre for Neurology and Neurosurgery, Liverpool, UK michael.jenkinson@liv.ac.uk.
Catherine J McMahonNeurosurgery, Northern Care Alliance NHS Foundation Trust, Salford, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHead injury in older adults is increasingly common, often caused by low-impact falls. A significant proportion of these patients are taking oral anticoagulants (OACs) to prevent stroke or thromboembolism. When traumatic bleeding within the head occurs, OACs are usually stopped to reduce the risk of worsening haemorrhage; however, prolonged interruption increases the risk of stroke, systemic thromboembolism and death. There is currently no consensus on when it is safest to restart OACs. Direct oral anticoagulants (DOACs) are now widely prescribed and may offer advantages over warfarin. This trial aims to determine the safest and most effective timing to start/restart a DOAC after a traumatic intracranial haemorrhage (tICH).

methodsThis is a phase III, multi-centre, randomised controlled trial. Adults with tICH who were taking an OAC before injury will be recruited across approximately 20 trauma networks in the UK. Eligible participants will be randomised to restart DOAC therapy either 1 week or 4 weeks after tICH. The primary outcome is the proportion of patients with a haemorrhagic or thrombotic event within 12 weeks of tICH. Secondary outcomes include time-to-first haemorrhagic or thrombotic event, survival, functional status, quality of life and health resource use. Follow-up will occur at 6, 12 and 26 weeks, with data analysed on an intention-to-treat basis. Health economic and qualitative sub-studies will run alongside the main trial. DISCUSSION: This study addresses a major area of clinical uncertainty. By directly comparing 1-week versus 4-week re-initiation of OAC, this trial will provide robust evidence to guide clinical practice in a tICH population at high risk of both bleeding and thrombotic complications. Findings will inform patient counselling, acute care protocols and guideline development. ETHICS AND DISSEMINATION SECTION: Ethical approval has been obtained from the Berkshire Research Ethics Committee (24/SC/0298). Written informed consent will be obtained from all participants or their legal representatives before enrolment. Findings will be disseminated through peer-reviewed publications, scientific conferences, trial registry reporting and patient-facing summaries, with the aim of informing future guidance on anticoagulation management following tICrH.

trial registrationNCT06322953.

Indexed as

AnticoagulantsIntracranial Hemorrhage, TraumaticStrokeThromboembolismAdministration, OralClinical Trials, Phase III as TopicDrug Administration ScheduleHemorrhageHumansMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicTime FactorsTreatment InterruptionUnited KingdomAnticoagulantsAnticoagulationStrokeTRAUMA MANAGEMENT

Identifiers

PMID42754280
PMCPMC13599854

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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.