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Completed

NCT Number: NCT04064489

Thromboembolic Risk Stratification by TRiP(Cast) Score to Guide Physicians in Preventive Treatment Prescriptions for Patients With Lower Limb Trauma Requiring Brace or castING.

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Universitaire Saint-Luc, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consultation in one of the emergency department participating in the study,
  • Isolated trauma from lower limb,
  • Rigid (plaster or resin) or semi-rigid immobilization for an assumed duration of at least 7 days,
  • Adults (18 years),
  • Affiliated patient or beneficiary of a social security,
  • Patient with prior informed consent.

Exclusion criteria

  • Patient with anticoagulant treatment at the time of trauma,
  • Trauma requiring hospitalization of more than 48 hours,
  • Co-morbidity(s) requiring hospitalization of more than 48 hours at the time of inclusion,
  • Any factor making 90-day follow-up impossible,
  • Pregnant, nursing or childbearing patient,
  • Patient deprived of liberty by judicial or administrative decision,
  • Patient undergoing psychiatric care under duress,
  • Patient subject to a legal protection measure,
  • Patient unable to give free and informed consent.

Treatment and study plan

TRIPscore

Other

TRIPcast score calculation

Primary outcomes

  1. Rate of symptomatic venous thromboembolic events (deep vein thrombosis and / or pulmonary embolism) among patients with a TRiP(cast) score < 7

    Time frame: Day 90

    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

Secondary outcomes

  1. Rate of prescription for thromboprophylaxis

    Time frame: Day 1

    comparison between the two period

  2. Rate of symptomatic venous thromboembolic events (deep vein thrombosis and / or pulmonary embolism) (whole population)

    Time frame: Day 90

    comparison between the two period

  3. The rate of complications of preventive anticoagulant treatment (bleeding)

    Time frame: Day 90

    comparison between the two period

  4. The direct cost of preventive anticoagulant treatment when the TRiP(cast) score is applied compared to current practices

    Time frame: Day 90

    treatment, nurse, blood test...cost of care

  5. Physicians' satisfaction using likert's scale

    Time frame: Day 1

    5 level ladder : from totally unsatisfied to totally satisfied

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Bichat Hospital
  • CHU Rennes - Hopital Pontchaillou
  • Centre Hospitalier Régional d'Orléans
  • Centre Hospitalier d'Agen
  • Centre Hospitalier de Cholet
  • Centre Hospitalier de Saint-Brieuc
  • Centre Hospitalier le Mans
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • Hôpital Cochin
  • Nantes University Hospital
  • Poitiers University Hospital
  • University Hospital, Grenoble
  • University Hospital, Toulouse
  • University Hospital, Tours

Registry information

Official study title

Thromboembolic Risk Stratification by TRIP Score (Cast) to Guide Physicians in Preventive Treatment Prescriptions for Patients With Lower Limb Trauma Requiring Brace or Casting.

Acronym: CASTING

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 22, 2019
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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