Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416280
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-06
Brief Title:
Inter-observer Reliability of the TRiPCast Score in Patients With Trauma to a Lower Limb Requiring Immobilisation
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
Inter-observer Reliability of the Assessment of the Risk of Developing a Venous Thromboembolic Event the TRiPCast Score in Patients With Trauma to a Lower Limb Requiring Immobilisation
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCASTING
Brief Summary:
The aim of the study isto evaluate the inter-observer reliability of the assessment of venous thromboembolic risk using the TRiPcast score in patients presenting with trauma to a lower limb requiring immobilisation and of the clinicians assessment using the physicians implicit probability gestalt compared with the use of the TRiPcast score
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 13 to 27 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 TRiPcast 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 TRiPcast score 7 had a 3-month rate of symptomatic thromboembolic events of 070 95 CI 021-117 Use of the TRiPcast score reduced the rate of anticoagulation prescriptions by 26 245 versus 504 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 clinicians 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 TRiPcast score in patients presenting with trauma to a lower limb requiring immobilisation and of the clinicians assessment using the physicians implicit probability gestalt compared with the use of the TRiPcast score
In the CASTING study randomised stepped-wedge trial patients not receiving thromboprophylaxis on the basis of a TRiPcast score 7 had a 3-month rate of symptomatic thromboembolic events of 070 95 CI 021-117 Use of the TRiPcast score reduced the rate of anticoagulation prescriptions by 26 245 versus 504 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 clinicians 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 TRiPcast score in patients presenting with trauma to a lower limb requiring immobilisation and of the clinicians assessment using the physicians implicit probability gestalt compared with the use of the TRiPcast score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None