In short
This article provides information about 1 ongoing clinical trial investigating treatments for patients with lower limb injuries requiring immobilization. The trial is comparing different medications to prevent dangerous blood clots that can form when the leg is kept still in a cast or brace.
Clinical trial locations
Study Comparing Rivaroxaban and Drug Combination for Preventing Blood Clots in Patients with Lower Limb Injuries Requiring Immobilization
This trial is taking place in France and focuses on patients who have experienced a lower limb injury that requires immobilization, such as wearing a cast or brace. When a leg is kept still for an extended period, there is an increased risk of developing blood clots in the veins, a condition known as venous thromboembolism. These blood clots can be dangerous if they travel to the lungs, causing a potentially serious complication called pulmonary embolism.
Main inclusion criteria:
- Must be 18 years of age or older
- Must have a lower limb injury requiring a rigid or semi-rigid support to keep the limb still for at least 2 weeks
- Must have been seen in the Emergency Department of a participating hospital
- Hospital stay should be planned for 72 hours or less
- Must have a TRiP(cast) score of 7 or higher, which is a scoring system used to assess the risk of developing blood clots
- Must have full insurance coverage
- Must provide signed informed consent after understanding the study details
Main exclusion criteria:
- Patients who are not considered at high risk of venous thromboembolism, with a risk score below 7
- Patients outside the specified age range
- Patients who belong to vulnerable populations requiring special protection
Focus and goal of the trial:
The main goal of this study is to compare two different approaches to preventing blood clots in patients with immobilized lower limb injuries. The trial aims to determine whether Rivaroxaban, a medication taken by mouth as a tablet, is as effective as low-molecular weight heparin, which is given through injections under the skin. The study will monitor participants for 45 days after starting treatment to see if either medication prevents symptomatic blood clots, such as deep vein thrombosis or pulmonary embolism. Participants will be randomly assigned to receive either Rivaroxaban or one of several types of low-molecular weight heparin for the duration of their immobilization period, which is expected to last at least 2 weeks and up to 50 days.
Investigational drugs being tested:
Rivaroxaban is an oral anticoagulant medication that works by blocking a specific protein in the blood called Factor Xa, which is essential for blood clot formation. It is being tested to see if it can prevent blood clots as effectively as the standard treatment, without causing more side effects. The advantage of Rivaroxaban is that it comes in tablet form and does not require regular blood monitoring.
Low-molecular weight heparin is the standard treatment currently used to prevent blood clots in patients at high risk. It is administered through injections under the skin. In this trial, several types of low-molecular weight heparin may be used, including tinzaparin sodium, enoxaparin sodium, nadroparin calcium, or dalteparin sodium. This medication serves as the comparison treatment to evaluate whether Rivaroxaban is a suitable alternative.
Summary
Currently, there is one ongoing clinical trial investigating prevention of blood clots in patients with lower limb injuries requiring immobilization. The trial is being conducted in France and is focused on comparing an oral medication, Rivaroxaban, with the standard injectable treatment, low-molecular weight heparin. The study targets patients who are at high risk of developing blood clots during their recovery period when their leg must remain still in a cast or brace. The trial is expected to continue until September 2026 and will provide valuable information about the best approach to prevent serious complications related to blood clots in this patient population.
