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Randomized Controlled Trial Multicenter Study
Targeted prophylactic anticoagulation based on the TRiP(cast) score in patients with lower limb immobilisation: a multicentre, stepped wedge, randomised implementation trial.
- Delphine Douillet, Andrea Penaloza, Damien Viglino, Jean-Jacques Banihachemi, Anmar Abboodi, Mathilde Helderlé, Emmanuel Montassier, Fréderic Balen, Christian Brice, Saïd Laribi, Thibault Duchenoy, Philippe Vives, Louis Soulat, Nicolas Marjanovic, Thomas Moumneh, Dominique Savary, Jérémie Riou, and Pierre-Marie Roy.
- Emergency Department, Health Faculty, Angers University Hospital, Angers, France; UMR MitoVasc CNRS 6015 - INSERM 1083, Equipe CARME, UNIV Angers, Angers, France; F-CRIN INNOVTE Network, Saint-Etienne, France. Electronic address: delphine.douillet@chu-angers.fr.
- Lancet. 2024 Mar 16; 403 (10431): 105110601051-1060.
BackgroundProphylactic anticoagulation in emergency department patients with lower limb trauma requiring immobilisation is controversial. The Thrombosis Risk Prediction for Patients with Cast Immobilisation-TRiP(cast)-score could identify a large subgroup of patients at low risk of venous thromboembolism for whom prophylactic anticoagulation can be safely withheld. We aimed to prospectively assess the safety of withholding anticoagulation for patients with lower limb trauma at low risk of venous thromboembolism, defined by a TRiP(cast) score of less than 7.MethodsCASTING was a stepped-wedge, multicentre, cluster-randomised trial with blinded outcome assessment. 15 emergency departments in France and Belgium were selected and randomly assigned staggered start dates for switching from the control phase (ie, anticoagulation prescription according to the physician's usual practice) to the intervention phase (ie, targeted anticoagulation according to TRiP(cast) score: no prescription if score <7 and anticoagulation if score was ≥7). Patients were included if they presented to a participating emergency department with lower limb trauma requiring immobilisation for at least 7 days and were aged 18 years or older. The primary outcome was the 3-month cumulative rate of symptomatic venous thromboembolism during the intervention phase in patients with a TRiP(cast) score of less than 7. The targeted strategy was considered safe if this rate was less than 1% with an upper 95% CI of less than 2%. The primary analysis was performed in the intention-to-treat population. This study is registered at ClinicalTrials.gov (NCT04064489).FindingsBetween June 16, 2020, and Sept 15, 2021, 15 clusters and 2120 patients were included. Of the 1505 patients analysed in the intervention phase, 1159 (77·0%) had a TRiP(cast) score of less than 7 and did not receive anticoagulant treatment. The symptomatic venous thromboembolism rate was 0·7% (95% CI 0·3-1·4, n=8/1159). There was no difference between the control and the intervention phases in the cumulative rate of symptomatic venous thromboembolism or in bleeding rates.InterpretationPatients with a TRiP(cast) score of less than 7 who are not receiving anticoagulation have a very low risk of venous thromboembolism. A large proportion of patients with lower limb trauma and immobilisation could safely avoid thromboprophylaxis.FundingFrench Ministry of Health.Copyright © 2024 Elsevier Ltd. All rights reserved.
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