An interventional study of TRIPscore in Lower Limb Trauma, Venous Thromboembolism and Stratification, sponsored by University Hospital, Angers. Completed at 15 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-11.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Prevention
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.
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's enrollment of 2,123 is above the median of 196 across 436 interventional studies indexed under Thromboembolism.
Browse Thromboembolism studies →University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
No specific instructions for prescribing prophylaxis or not
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)
Other: TRIPscore
TRIPcast score calculation
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
Time frame: Day 90
Rate of prescription for thromboprophylaxis
comparison between the two period
Time frame: Day 1
Rate of symptomatic venous thromboembolic events (deep vein thrombosis and / or pulmonary embolism) (whole population)
comparison between the two period
Time frame: Day 90
The rate of complications of preventive anticoagulant treatment (bleeding)
comparison between the two period
Time frame: 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
Time frame: Day 90
Physicians' satisfaction using likert's scale
5 level ladder : from totally unsatisfied to totally satisfied
Time frame: Day 1
Plan to share: No — 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.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Angers