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| Name | Class |
|---|---|
| Centre Hospitalier de Cholet | OTHER |
| Centre Hospitalier de Saint-Brieuc | OTHER |
| Bichat Hospital | OTHER |
| Hôpital Cochin |
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Non-surgical traumas to the lower limbs that require orthopedic immobilisation (plaster or splint) are a frequent reason for going to accident and emergency. Due to venous stasis caused by immobilisation, hypercoagulable states and vascular injuries brought on by the trauma, these patients are at risk of developing VTE. For this reason, it is current practice in France and Belgium for the majority of patients to receive a preventative anticoagulant treatment. However, the benefit of this treatment, which has a considerable cost, is controversial. Contrary to French recommendations, American recommendations from 2012 actually advise against systematic preventative medicine, with prevention appearing to be effective primarily in studies with restrictive inclusion criteria. The most significant randomised controlled study on the subject did not show the benefit of low-molecular-weight heparin (LMWH) on the rate of symptomatic VTE among 1,435 non-selected patients. Therefore, in 2017, the Cochrane meta-analysis concluded that stratification of the risk of thromboembolism is required.
For this purpose, in collaboration with the Dutch team of Nemeth et al. we have recently developed a risk stratification model that takes into consideration the patient's characteristics, the type of immobilisation and the severity of the trauma: the TRiP(cast) score. This score is applied retrospectively to a large cohort and demonstrates excellent prognostic performances (AUC (area under the curve) of 0.74). In addition, when using a <7 limits, it makes it possible to identify a large group of patients at very low risk of developing VTE (negative predictive value: 99.2%).
The aim of the CASTING study is to prospectively demonstrate the reliability and utility of the TRiP(cast) score by showing that patients with orthopaedic immobilisation of a lower limb who are not receiving preventative treatment on the basis of a TRiP(cast) score of <7 have a very low rate of symptomatic VTE, which allows for a significant reduction in prescriptions of anticoagulants in comparison with prior practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neutral | No Intervention | No specific instructions for prescribing prophylaxis or not | |
| TRIPscore | Active Comparator | calculation of the TRIPcast score and prescription of prophylactic or not according to the result (score > or = 7 : treatment (low molecular weight heparin or fondaparinux); score < 7 : no treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRIPscore | Other | TRIPcast score calculation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of symptomatic venous thromboembolic events (deep vein thrombosis and / or pulmonary embolism) among patients with a TRiP(cast) score < 7 | To demonstrate the reliability and safety of the decision not to implement thromboprophylaxis in patients with orthopedic immobilization for lower extremity trauma and Trip(cast) < 7 | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of prescription for thromboprophylaxis | comparison between the two period | Day 1 |
| Rate of symptomatic venous thromboembolic events (deep vein thrombosis and / or pulmonary embolism) (whole population) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Marie Roy, MD PhD | University Hospital, Angers | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Universitaire Saint-Luc | Brussels | Belgium | ||||
| Centre Hospitalier d'Agen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38368901 | Derived | Douillet D, Penaloza A, Viglino D, Banihachemi JJ, Abboodi A, Helderle M, Montassier E, Balen F, Brice C, Laribi S, Duchenoy T, Vives P, Soulat L, Marjanovic N, Moumneh T, Savary D, Riou J, Roy PM. Targeted prophylactic anticoagulation based on the TRiP(cast) score in patients with lower limb immobilisation: a multicentre, stepped wedge, randomised implementation trial. Lancet. 2024 Mar 16;403(10431):1051-1060. doi: 10.1016/S0140-6736(23)02369-3. Epub 2024 Feb 15. | |
| 34183341 |
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Individual participant data will not be available. The study protocol, the Statistical Analysis Plan, Informed consent form will be available immediately following publication. No end date.
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| OTHER |
| University Hospital, Toulouse | OTHER |
| University Hospital, Grenoble | OTHER |
| Centre Hospitalier Régional d'Orléans | OTHER |
| Poitiers University Hospital | OTHER |
| Nantes University Hospital | OTHER |
| Cliniques universitaires Saint-Luc- Université Catholique de Louvain | OTHER |
| University Hospital, Tours | OTHER |
| CHU Rennes - Hopital Pontchaillou | OTHER |
| Centre Hospitalier le Mans | OTHER |
| Centre Hospitalier d'Agen | OTHER |
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comparison between the two period
| Day 90 |
| The rate of complications of preventive anticoagulant treatment (bleeding) | comparison between the two period | Day 90 |
| The direct cost of preventive anticoagulant treatment when the TRiP(cast) score is applied compared to current practices | treatment, nurse, blood test...cost of care | Day 90 |
| Physicians' satisfaction using likert's scale | 5 level ladder : from totally unsatisfied to totally satisfied | Day 1 |
| Agen |
| France |
| CHU Angers | Angers | France |
| Centre Hospitalier de Cholet | Cholet | France |
| Centre Hospitalier Universitaire de Grenoble | Grenoble | France |
| Centre Hospitalier Le Mans | Le Mans | France |
| Centre Hospitalier Universitaire de Nantes | Nantes | France |
| Centre Hospitalier d'Orléans | Orléans | France |
| APHP Bichat | Paris | France |
| APHP Cochin | Paris | France |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | France |
| Centre Hospitalier Universitaire de Rennes | Rennes | France |
| Centre Hospitalier de Saint-Brieuc | Saint-Brieuc | France |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | France |
| Centre Hospitalier Universitaire de Tours | Tours | France |
| Derived |
| Douillet D, Riou J, Thoma M, Moumneh T, Darsonval A, Trinh-Duc A, Hugli O, Chauvin A, Penaloza A, Roy PM. Thromboembolic risk stratification by TRiP(cast) score to rationalise thromboprophylaxis in patients with lower leg trauma requiring immobilisation: a study protocol of the casting stepped-wedge cluster randomised trial. BMJ Open. 2021 Jun 28;11(6):e045905. doi: 10.1136/bmjopen-2020-045905. |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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