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Venous ThromboembolismCCASTINGNCT06416280

Inter-observer Reliability of the TRiP(Cast) Score in Patients With Trauma to a Lower Limb Requiring Immobilisation

An observational study of Venous Thromboembolism and Deep Vein Thrombosis, run by University Hospital, Angers at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the study isto evaluate the inter-observer reliability of the assessment of venous thromboembolic risk using the TRiP(cast) score in patients presenting with trauma to a lower limb requiring immobilisation, and of the clinicians' assessment using the physician's implicit probability (gestalt) compared with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Assessment of the TRiP(cast) score
How many people
302 participants
Where
1 siteFrance
Study dates
16 May 2024to 30 Dec 2025
Phase
Observational
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
  • Adult, Older adult

Study population: Emergency department patients

Who may be able to join

  • Consultation in one of the emergency departments participating in the study,
  • Isolated trauma to a lower limb,
  • Rigid immobilisation (plaster or resin) or semi-rigid immobilisation for an expected duration of at least 7 days,
  • Patient over 18 years of age,
  • Patient affiliated to or benefiting from a social security scheme,
  • Patients who have signed a prior informed consent form

Who cannot join

  • Patient taking anticoagulant treatment at the time of the trauma,
  • Trauma requiring hospitalisation for more than 48 hours,
  • Pregnant, breast-feeding or parturient patients,
  • Patient deprived of liberty by judicial or administrative decision,
  • Patient under compulsory psychiatric care,
  • Patient under legal protection,
  • Patients unable to give their free and informed consent

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • DOUILLET Delphine

    Angers

    Delphine DOUILLET, delphine.douillet@chu-angers.fr

    Recruiting

Other trials in France

About this study

Official title: Inter-observer Reliability of the Assessment of the Risk of Developing a Venous Thromboembolic Event, the TRiP(Cast) Score, in Patients With Trauma to a Lower Limb Requiring Immobilisation

The aim of the study isto evaluate the inter-observer reliability of the assessment of venous thromboembolic risk using the TRiP(cast) score in patients presenting with trauma to a lower limb requiring immobilisation, and of the clinicians' assessment using the physician's implicit probability (gestalt) compared with the use of the TRiP(cast) score.

Read the detailed description

Trauma to the lower limbs requiring orthopedic immobilisation (plaster cast or splint) is a frequent reason for seeking emergency care. Because of the venous stasis caused by immobilisation, hypercoagulability and vascular lesions induced by the trauma, these patients are at risk of developing a venous thromboembolic event (VTE). This risk is estimated at around 2% (95% CI 1.3 to 2.7). To reduce the risk of thrombosis, preventive anticoagulants, mainly low molecular weight heparins (LMWH) and fondaparinux, have been shown to be beneficial. However, not all patients have the same thromboembolic risk factors. A targeted strategy should therefore be used to avoid prescribing treatment to low-risk patients and to prescribe it to the sub-group of patients at high risk. The TRiP(cast) score has been developed and validated for this purpose.

In the CASTING study (randomised stepped-wedge trial), patients not receiving thromboprophylaxis on the basis of a TRiP(cast) score <7 had a 3-month rate of symptomatic thromboembolic events of 0.70% (95% CI: 0.21-1.17). Use of the TRiP(cast) score reduced the rate of anticoagulation prescriptions by 26% (24.5% versus 50.4%) without increasing the rate of thromboembolic events at 3 months. Since this study, French recommendations concerning the prescription of anticoagulation treatments have been updated.

Since this study, French recommendations concerning the prescription of preventive anticoagulant treatment have been updated by the SFMU (French Society of Emergency Medicine) and the SFMV (French Society of Vascular Medicine). They were presented in June 2023 and are now applied in all emergency facilities. During the review for the publication of the CASTING study, it was discussed whether it would be useful to evaluate the reliability of this score.

However, the reliability of the measurement and the reproducibility of the score have never been assessed. Given the importance of assessing the risk of venous thromboembolism in patients with lower-limb trauma when deciding whether or not to prescribe thromboprophylaxis, this assessment is essential.

Although this score appears to be objective, there are still items where interpretation may be different. For example, the type of immobilisation cannot be transposed perfectly to all existing immobilisation methods. This study will also be carried out in other European countries. The types of immobilisation vary considerably from one country to another, and the interpretation of certain items could be different. The interpretation of patient characteristics may also vary.

Furthermore, this score has never been compared with the clinician's implicit "gestalt" probability, which is used to define patients at risk of venous thromboembolic events.

It is a real challenge when implementing scores to assess their added value compared with clinical intuition. The use of scores has an initial educational objective, but it is important to know whether clinical intuition would be sufficient to assess this venous thromboembolic risk.

The aim of the study is to evaluate the inter-observer reliability of the assessment of venous thromboembolic risk using the TRiP(cast) score in patients presenting with trauma to a lower limb requiring immobilisation, and of the clinicians' assessment using the physician's implicit probability (gestalt) compared with the use of the TRiP(cast) score.

Being tested
Assessment of the TRiP(cast) score
Medical subject headings
Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism

What participants receive

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

  • Assessment of the TRiP(cast) scoreOther

    In patients presenting to the emergency department with trauma to a lower limb, the TRiP(cast) score is assessed in accordance with the recommendations. If the patient does not object. The attending physician will then be asked to fill in his implicit assessment of the risk of venous thromboembolism on a paper CRF and then to complete his assessment of the TRiP(cast) score. He will then be free to decide whether or not to anticoagulate the patient.

    At the same time, a doctor not involved in the patient's care will assess the TRiP(cast) score and record it on a paper CRF. The second doctor's assessment will be independent and will have no impact on the patient's management.

    The CRFs will then be analysed and stored. Data will be anonymised during data collection and each patient will be assigned an anonymity number.

What is being measured

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

  1. The primary aim is to assess the inter-observer reliability of venous thromboembolic risk assessment using the TRiP(cast) score in patients with lower limb trauma requiring immobilisation.

    Outcome measure : The rate of agreement or "concordance" will be estimated by the Kappa coefficient.

    Measured: Day 0

Timeline

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

  1. First posted16 May 2024
  2. Study start16 May 2024
  3. Primary completion20 May 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
302 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06416280
Sponsor's protocol ID
24_0131
Acronym
CCASTING
Status last verified
May 2024
First submitted
6 May 2024
Last updated
17 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Venous Thromboembolism and Deep Vein Thrombosis, run by University Hospital, Angers at 1 site in France.

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 7 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: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

Results are not available in the source record.

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

Contact Delphine DOUILLET ((0)241353637 ext. +33, Delphine.Douillet@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary aim is to assess the inter-observer reliability of venous thromboembolic risk assessment using the TRiP(cast) score in patients with lower limb trauma requiring immobilisation. (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 May 2024.

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