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Leg cast clot risk: pills vs. shots in massive 10,000-Person trial

NCT ID NCT06370273

Prevention Sponsor: Queen Mary University of London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study looks at the best way to prevent blood clots in people who have a leg cast or splint after an injury. For those at high risk of clots, it compares pills to standard injections. For low-risk people, it checks if any medication is better than just advice. Over 10,000 participants will be followed for 90 days.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 10,044 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \>/= 16 years * Placed in temporary lower limb immobilisation (rigid cast or brace) as a result an injury that occurred within the last 7 calendar days Exclusion Criteria: * Hospital admission is required direct from the emergency department, minor injuries unit, or fracture clinic setting with an expected length of stay \>2 calendar days. * Absolute contraindication or known hypersensitivity to anticoagulants, including history of end stage renal failure (eGFR \<20ml/min/1.73m2), hepatic failure or use of concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole), HIV protease inhibitors (e.g. ritonavir) or active substances strongly inhibiting elimination pathways such as CYP3A4 or P-gp (such as clarithromycin, erythromycin or dronaderone) or a history of heparin induced thrombocytopenia. * Pregnancy, actively seeking conception, or active breastfeeding. * Preceding use of anticoagulant treatment for \>3 calendar days at prophylactic or therapeutic dose. * Prior enrolment in the TiLLI study. * Non-rigid immobilisation (crepe bandage, tubigrip support, strapping). * Time since prescription of rigid immobilisation \>3 calendar days * Co-enrolment onto a CTIMP where an anticoagulant is administered * People lacking the capacity to consent * Inability or refusal to use acceptable contraception up until after the last administration of IMP. Only applicable for women of childbearing potential who have been randomised to receive apixaban or rivaroxaban

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Conditions

The condition(s) this trial relates to.

Leg Injuries thrombotic disease venous thromboembolism prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Injury leg Thrombosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Barts Health NHS Trust

    RECRUITING

    London, United Kingdom

  • Epsom and St Helier University Hospitals NHS Trust

    RECRUITING

    Carshalton, Surrey, United Kingdom

  • Hull Teaching Hospitals NHS Trust

    RECRUITING

    Hull, United Kingdom

  • Kings College Hospital NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • Northern Care Alliance NHS Foundation Trust

    RECRUITING

    Manchester, United Kingdom

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