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Lower Limb TraumaCASTINGNCT04064489

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

A study testing TRIPscore in people with Lower Limb Trauma and Venous Thromboembolism, run by University Hospital, Angers at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TRIPscore
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,123 participants
Where
15 sitesin 2 countries
Study dates
16 Jun 2020to 4 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 9Show fewer
  • Patient undergoing psychiatric care under duress,
  • Patient subject to a legal protection measure,
  • Patient unable to give free and informed consent.

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

France14 sites

  • Centre Hospitalier d'Agen

    Agen

  • CHU Angers

    Angers

  • Centre Hospitalier de Cholet

    Cholet

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble

  • Centre Hospitalier Le Mans

    Le Mans

  • Centre Hospitalier Universitaire de Nantes

    Nantes

  • Centre Hospitalier d'Orléans

    Orléans

  • APHP Bichat

    Paris

  • APHP Cochin

    Paris

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers

  • Centre Hospitalier Universitaire de Rennes

    Rennes

  • Centre Hospitalier de Saint-Brieuc

    Saint-Brieuc

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse

  • Centre Hospitalier Universitaire de Tours

    Tours

Other trials in France

Belgium1 site

  • Clinique Universitaire Saint-Luc

    Brussels

Other trials in Belgium

About this study

Official 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.

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.

Being tested
TRIPscore
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRIPscoreOther

    TRIPcast score calculation

Study groups in NCT04064489
Study groupRoleWhat they receive
neutralNo interventionNo specific instructions for prescribing prophylaxis or not
TRIPscoreActive comparatorcalculation 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)
Receives: Other: TRIPscore

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 90

Secondary outcomes (5)

  1. Rate of prescription for thromboprophylaxis

    comparison between the two period

    Measured: Day 1

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

    comparison between the two period

    Measured: Day 90

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

    comparison between the two period

    Measured: Day 90

  4. 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

    Measured: Day 90

  5. Physicians' satisfaction using likert's scale

    5 level ladder : from totally unsatisfied to totally satisfied

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2019
  2. Study start16 Jun 2020
  3. Primary completion4 Feb 2022
  4. Study completion4 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04064489
Sponsor's protocol ID
49RC19_0027
Acronym
CASTING
Status last verified
Aug 2022
First submitted
19 Aug 2019
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 38368901

  • 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.

    PubMed 34183341

Questions about this trial

What is this clinical trial studying?

A study testing TRIPscore in people with Lower Limb Trauma and Venous Thromboembolism, run by University Hospital, Angers at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04064489, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

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