Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509905-62-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score <7 have a very low risk of VTE and could be safely manage without prophylactic treatment. Conversely, patients with a score ≥ 7 have a high-risk of VTE and require a prophylactic anticoagulant treatment. Low molecular weight heparins (LMWH) have been shown to be effective in this indication. However, in the CASTING study, the 3-month symptomatic VTE rate was 2.6% in this subgroup despite LMWH prophylactic treatment. This result suggests that LMWH are not sufficiently effective in this particular subgroup of high-risk patients. Direct oral anticoagulants, and in particular rivaroxaban, may be an effective and safe alternative to LMWH. In the PRONOMOS study, comparing LMWH with rivaroxaban in patients who had undergone non-major lower limb surgery, the relative risk of symptomatic VTE was 0.25 (95% CI = 0.09 - 0.75) in favor of rivaroxaban 10mg. No significant increase in bleeding was found. In addition, as LMWH treatment requires subcutaneous daily injections, the use of rivaroxaban may positively impact patients' quality of life as well as being effective in medico-economic terms.
The aims of this study are to demonstrate that rivaroxaban is at least as effective, easier to use and more efficient than LMWH in patients with trauma to the lower limb requiring immobilisation and deemed to be at risk of venous thromboembolism (TRiP(cast) score ≥ 7). High-risk patients are randomized to receive either rivaroxaban or LMWH. They are followed up at 45 days and 90 days to assess the occurrence of thrombotic events or bleeding, as well as their satisfaction with the treatment received.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban arm | Experimental |
| |
| Low-molecular-weight heparin arm | Active Comparator | Treatment with LMWH is the standard-of-care in this population of lower limb trauma patients at risk of thrombosis. The control group is therefore the group of patients who receive prophylactic anticoagulant treatment with LMWH for the duration of immobilization (i.e. until full mobilization with weight-bearing). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 10 MG | Drug | Administration of rivaroxaban 10 mg once daily to prevent venous thromboembolic events in patients with trauma to a lower limb. Consecutive patients with lower limb trauma and a TRiP(cast) score ≥ 7 are assessed for possible participation in the study. At the inclusion visit, if the patient meets the study's selection criteria, the investigator provides oral and written information (information letter written in a language the patient can understand) and answers any questions the patient may have. Depending on randomisation, the patient will receive either LMWH or rivaroxaban. The dose is rivaroxaban 10 mg orally once a day (no dosage adjustment). Treatment is started in the emergency department and continued at home for the duration of the immobilisation (i.e. until mobilisation with weight-bearing). The duration of treatment will be determined by the physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of symptomatic venous thromboembolic events (45 days non-inferiority) | The primary endpoint is the rate of symptomatic venous thromboembolic events (including deep vein thrombosis and/or pulmonary embolism and/or PE-related death) within 45 days (+/- 5 days) of inclusion. Symptomatic VTE is defined as follows:
| 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient self reported treatment satisfaction | The outcome is patient self-reported treatment satisfaction using the Anti-Clot Treatment Scales (ACTS) assessed at 45 days (+/- 5 days). | 45 days |
| Rate of symptomatic venous thromboembolic events (90 days superiority) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Delphine Douillet, Doctor | Contact | 0241353637 | Delphine.Douillet@chu-angers.fr | |
| Cindy Augereau, Mrs | Contact | 0241354143 | Cindy.Augereau@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Delphine Douillet, Doctor | University Hospital, Angers | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agen-Nerac Hospital, Emergency Department | Active, not recruiting | Agen | 47923 | France | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Open label with blind assessment of study's outcomes
|
| Low Heparin Molecular Weight | Drug | Administration of standard prophylactic anticoagulant treatment with LMWH for the duration of immobilisation (i.e. until full mobilisation with weight-bearing). Consecutive patients with lower limb trauma and a TRiP(cast) score ≥ 7 are assessed for possible participation in the study. At the inclusion visit, if the patient meets the study's selection criteria, the investigator provides oral and written information (information letter written in a language the patient can understand) and answers any questions the patient may have. Depending on randomisation, the patient will receive either LMWH or rivaroxaban. The dose of LMWH is free, given according to local practices and national recommendations. Treatment is started in the emergency department and continued at home for the duration of the immobilisation (i.e. until mobilisation with weight-bearing). The duration of treatment will be determined by the physician. |
|
This secondary outcome is the cumulative rate of symptomatic venous thromboembolism (i.e., deep venous thrombosis and/or pulmonary embolism) within the 90 days (± 7 days) after the inclusion. The definition of symptomatic VTE is the same as the primary outcome. |
| 90 days |
| Cumulative rates of major bleeding and of non-major clinically relevant bleeding (90 days) | The cumulative rates of major bleeding and of non-major clinically relevant bleeding at 90 days (± 7 days). Major bleeding is defined according to the International Society of Thrombosis and Haemostasis (ISTH) criteria and includes:
Clinically Relevant Non-Major Bleeding is defined as: - Any bleeding requiring hospitalisation or a medical intervention including temporary withholding of anticoagulant treatment to stop the bleeding. | 90 days |
| Incremental cost-utility ratio (rivaroxaban efficiency 45 days) | The incremental cost-utility ratio (costs per quality-adjusted life year (QALY) gained) assessed at 45 days after inclusion. Health-related quality of life will be collected using EQ-5D-5L self-administered questionnaires at each scheduled follow-up at 45 days (±/- 5). Resources consumed will be taken from french national Health Data System. | 45 days |
| Incremental cost-utility ratio (rivaroxaban efficiency 90 days) | The incremental cost-utility ratio (costs per quality-adjusted life year [QALY] gained) assessed at 90 days after inclusion. Health-related quality of life will be collected using EQ-5D-5L self-administered questionnaires at each scheduled follow-up at at 90 days (± 7). Resources consumed will be taken from french national Health Data System. | 90 days |
| Angers University Hospital, Emergency department |
| Recruiting |
| Angers |
| 49000 |
| France |
|
| Argenteuil hospital, Emergency department | Recruiting | Argenteuil | 95100 | France |
|
| Arpajon Hospital, Emergency Department | Withdrawn | Arpajon | 91294 | France |
| Caen University hospital, Emergency department | Withdrawn | Caen | 14000 | France |
| Tours University Hospital, Emergency department | Withdrawn | Chambray-lès-Tours | 37170 | France |
| Cholet Hospital, Emergency department | Recruiting | Cholet | 49300 | France |
|
| Clermont-Ferrand University Hospital, Emergency department | Recruiting | Clermont-Ferrand | 63000 | France |
|
| Simone Veil Hospital, Emergency Department | Recruiting | Eaubonne | 95600 | France |
|
| Eure-Seine Hospital, Emergency Departement | Active, not recruiting | Évreux | 27015 | France |
| Grenoble University Hospital, Emergency Department | Recruiting | Grenoble | 38000 | France |
|
| La Roche sur Yon Hospital | Not yet recruiting | La Roche-sur-Yon | 85000 | France |
|
| La Rochelle Hospital, Adult emergency departement | Recruiting | La Rochelle | 17000 | France |
|
| Le Mans Hospital, Emergency department | Recruiting | Le Mans | 72000 | France |
|
| Limoges University hospital, Emergency department | Recruiting | Limoges | 87000 | France |
|
| Edouard Herriot University Hospital, Emergency Department | Recruiting | Lyon | 69000 | France |
|
| Marseille University Hospital, Emergency department | Recruiting | Marseille | 13005 | France |
|
| Melun Hospital, Emergency Department | Recruiting | Melun | 77000 | France |
|
| Montpellier University Hospital, emergency department | Recruiting | Montpellier | 34000 | France |
|
| Nancy University Hospital, Emergency department | Not yet recruiting | Nancy | 54000 | France |
|
| Nantes University Hospital, Emergency department | Recruiting | Nantes | 44000 | France |
|
| Nice University Hospital, Emergency department | Withdrawn | Nice | 06000 | France |
| Niort Hospital, Emergency Department | Recruiting | Niort | 79000 | France |
|
| Lariboisière hospital, emergency department | Not yet recruiting | Paris | 75010 | France |
|
| Saint-Antoine Hospital, Emergency department | Recruiting | Paris | 75012 | France |
|
| La Pitié-Salpétrière Hospital, Emergency Department | Not yet recruiting | Paris | 75013 | France |
|
| Cochin Hospital, Emergency department | Recruiting | Paris | 75014 | France |
|
| St-Joseph Hospital, Emergency Department | Recruiting | Paris | 75014 | France |
|
| HEGP, Emergency Department | Recruiting | Paris | 75015 | France |
|
| Bichat Hospital, Adult Emergency department | Recruiting | Paris | 75018 | France |
|
| South Lyon University Hospital, Emergency department | Recruiting | Pierre-Bénite | 69495 | France |
|
| Poitiers University Hospital, Emergency department | Recruiting | Poitiers | 86000 | France |
|
| Rennes University Hospital, Emergency department | Recruiting | Rennes | 35000 | France |
|
| Rouen University Hospital, Emergency Department | Not yet recruiting | Rouen | 76000 | France |
|
| Strasbourg University Hospital, Emergency Department | Recruiting | Strasbourg | 67000 | France |
|
| Toulouse University Hospital, Emergency Department | Recruiting | Toulouse | 31000 | France |
|
| Vannes Hospital, Emergency Department | Recruiting | Vannes | 56000 | France |
|
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D017985 | Dalteparin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided