Health TrialsbyHealthPanel

Thromboprophylaxis in Lower Limb Immobilisation

ConditionsThrombosisInjury Leg
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16+
SponsorQueen Mary University of London

About this trial

The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury.

The main questions it aims to answer are:

* whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care) * whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots.

Participants will be assessed to be high risk (TiLLI High) or low risk (TiLLI Low). People who are at high risk of clots will have either tablets or injections to reduce their risk. People at low risk will receive tablets, injections or no medication.

Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidelines. The participants will be followed up for 90 days following randomisation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rivaroxaban

    Drug

    10mg once daily via oral ingestion

  • Apixaban

    Drug

    2.5mg twice daily via oral ingestion

  • Enoxaparin Injectable Solution

    Drug

    40mg once daily via subcutaneous injection

  • Tinzaparin Injectable Solution

    Drug

    4500 IU once daily via subcutaneous injection

  • Dalteparin Injectable Solution

    Drug

    5000 IU once daily via subcutaneous injection

  • Fondaparinux Injectable Product

    Drug

    2.5 mg once daily via subcutaneous injection

Treatment groups

10,044 Participants
are divided into 5 treatment groups
Group A: TiLLI-High InterventionActive comparator 2 interventions
Group B: TiLLI-High Routine CareActive comparator 4 interventions
Group C: TiLLI-Low Intervention 1 (DOAC)Active comparator 2 interventions
Group D: TiLLI-Low Intervention 2 (Parenteral prophylaxis)Active comparator 4 interventions
Group E: TiLLI-Low Routine CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Composite of net clinical benefit comprising clinical VTE event, major bleeding, and cause-specific mortality

To estimate and draw inferences on the difference in a composite outcome of net clinical benefit between treatment groups. A composite primary outcome of net clinical benefit, comprising symptomatic VTE events (any deep vein thrombosis or pulmonary embolism), major bleeding or cause-specific mortality (death from either pulmonary embolus or major bleeding) used as a binary variable ('1' is any event occurred, '0' if none of the events occurred).

Time frame
Within 90 days of randomisation

Secondary outcomes

1

Symptomatic VTE event occurrence

To compare symptomatic VTE events (any deep vein thrombosis or pulmonary embolism) (an individual component of primary composite outcome) between treatment groups as a binary variable ('1' if any event occurred, '0' if no event occurred). Symptomatic VTE events objectively defined by ISTH criteria.

Time frame
Within 90 days from randomisation
2

Major bleeding occurrence

To compare major bleeding events (an individual component of primary composite outcome) between treatment groups as a binary variable ('1' if any event occurred, '0' if no event occurred). Major bleeding events objectively defined by ISTH criteria.

Time frame
Within 42 days from randomisation
3

Cause-specific mortality occurrence

To compare cause-specific mortality events (an individual component of primary composite outcome) between treatment groups as a binary variable ('1' if any event occurred, '0' if no event occurred).

Time frame
Within 90 days from randomisation
4

Adverse and Serious adverse events

To estimate and draw inferences on the difference in complications (including clinically relevant non-major bleeding and surgical site bleeding) objectively defined by ISTH criteria, between treatment groups.

Time frame
Within 90 days from randomisation.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Queen Mary University of London

Lead sponsor

Source ClinicalTrials.gov
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