Thrombosis Clinical Trial
— TiLLIOfficial title:
Thromboprophylaxis in Lower Limb Immobilisation (TiLLI): a Multicentre Study Comprising Two Linked Open Label Phase III Randomised Controlled Trials Evaluating the Effectiveness and Cost Effectiveness of Different Methods of Pharmacological Prophylaxis for Patients With Temporary Lower Limb Immobilisation.
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.
Status | Not yet recruiting |
Enrollment | 10044 |
Est. completion date | February 2028 |
Est. primary completion date | February 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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 days Exclusion Criteria: - Hospital admission is required immediately with an expected length of stay >48h. - Absolute contraindication or known hypersensitivity to anticoagulants, including history of end stage renal failure (eGFR <15ml/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. - Ongoing use of anticoagulant treatment at prophylactic or therapeutic dose for alternate reason. - Prior enrolment in the study. - Non-rigid immobilisation (crepe bandage, tubigrip support, strapping). - Time since prescription of rigid immobilisation >72h. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Queen Mary University of London |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Within 90 days of randomisation | |
Secondary | 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. | Within 90 days from randomisation | |
Secondary | 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. | Within 42 days from randomisation | |
Secondary | 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). | Within 90 days from randomisation | |
Secondary | 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. | Within 90 days from randomisation. | |
Secondary | Medication adherence | To report participant adherence to allocated anticoagulant verified through digital response system. | Up to 42 days from randomisation | |
Secondary | Health utility (EQ-5D-5L) | To estimate and draw inferences on differences in quality-of-life measures between treatment groups. Using the EuroQol 5 Dimensions 5 Level (EQ-5D-5L), a validated instrument comprising a self-rated health VAS and a five-domain health status questionnaire related to daily activities. Will collect for 4 timepoints: pre injury (completed retrospectively within 7 days following randomisation), 7 days following randomisation, 42 days following randomisation, and 90 days following randomisation | Up to 90 days post randomisation. | |
Secondary | Patient satisfaction regarding the burdens and benefits of anticoagulation | To estimate and draw inferences on the acceptability of different prophylactic anticoagulants using the validated Anti Clot Treatment Scale (ACTS) for patients allocated to drug treatments. The scale is a 15-item patient-reported instrument of satisfaction with anticoagulation treatment, with separate internal measures of burden and benefits. | Collected within 42 days following randomisation when the participants stops study treatment. | |
Secondary | Hospital readmission/reattendance | To estimate and draw inferences on the difference in resource use (including hospital readmission/reattendance), cost, quality of life-adjusted survival and relative cost effectiveness between treatment groups. Using bespoke Case Report Forms and review of EHR, research staff to collect information on resources required to deliver subsequent care reviews (including scheduled clinic and unscheduled hospital attendance), and investigations. | Within the first 90 days. | |
Secondary | Health and social care resource use | To estimate the health and social care resource use and costs and the relative cost effectiveness between treatment groups. Using bespoke Case Report Forms and review of EHR, research staff to collect information on health and social care resource use. | Within the first 90 days | |
Secondary | Patient longer term outcome VTE and bleeding data | To estimate longer term outcomes, such as post thrombotic syndrome, chronic thromboembolic pulmonary hypertension and bleeding complications and draw inferences on cost effectiveness, by using an existing VTE model with risk-adjusted, population specific effect estimates from this study. This will allow efficient, value for money inferences to made about long-term sequelae of VTE events and determine whether detailed long-term follow-up of participants would be worthwhile. Clinically relevant non-major bleeding events, major bleeding events and symptomatic bleeding events objectively defined by ISTH criteria. | Informed by directly measured events up to 90 days. |
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