Study of Blood Clot Prevention Methods During Temporary Leg Immobilisation After Injury Comparing Tablets and Injections for High and Low Risk Patients A Phase 3 Randomized Trial

What this Trial Is About

The trial investigates the clinical and cost effectiveness of different medicines to prevent blood clots in people with a leg injury treated with a plaster cast or splint. It focuses on whether tablets are as effective as injections for people at high risk of blood clots, and whether any medication is better than no medication for those at low risk. This study is a Phase 3 prevention trial involving patients who have been immobilized due to leg injury. Participants are grouped by risk level into high risk TiLLI-High and low risk TiLLI-Low. High-risk participants are randomly assigned to receive either oral tablets Rivaroxaban or Apixaban or daily injections Enoxaparin, Tinzaparin, Dalteparin, or Fondaparinux. Low-risk participants are randomized to tablets, injections, or no medication. Medications are given for the length of immobilization or up to 42 days, following current guidelines. The study is open-label, and patients and doctors know the assigned treatment. Participants will be followed for 90 days after starting the study to monitor blood clots, bleeding, and other health outcomes through medical record reviews and contact as needed. Researchers will collect data on medication adherence, patient satisfaction, hospital readmissions, and health resource use. Safety is monitored by an independent panel throughout. The study aims to improve treatment options and reduce healthcare costs for patients with leg injuries requiring immobilization.

Thromboprophylaxis in Lower Limb Immobilisation