A Prospective Study to Assess the Risk Factors That Contribute to Thrombosis in Patients With Lower Limb Injuries.
NCT ID: NCT04608591
Last Updated: 2020-10-29
Study Results
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Basic Information
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UNKNOWN
3500 participants
OBSERVATIONAL
2018-12-01
2023-12-01
Brief Summary
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* To do this we will collect data on 3500 patients who present with lower limb injury requiring immobilisation to the Emergency Departments of the six hospitals named.
* We will assess their risk factors for venous thrombosis at the time of presentation and contact them at twelve weeks to assess if they have had a VTE in order to develop a risk scoring system which can be used to predict the likelihood of VTE development
* This risk scoring system can then be used to identify high risk patients who may benefit from thromboprophylaxis.
Detailed Description
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The Multiple Environmental and Genetic Assessment of risk factors for venous thrombosis (MEGA) study was a case-control study designed to identify risk factors for a first VTE. A sub-analysis of this study reviewed 230 patients who had lower limb trauma with cast immobilisation who developed VTE. Based on this data a risk assessment score was derived (termed "L-TRiP" \[Leiden-Thrombosis Risk Prediction for patients with cast immobilization\] score) in order to identify high risk patients who may benefit from VTE prophylaxis. However, this risk assessment tool has not been prospectively validated in a study.
We have carried out a pilot study to assess the feasibility of a large scale, adequately powered multi-centre study aimed at prospective identification of a high VTE-risk group of patients. This study was presented at the International Society on Thrombosis and Haemostasis meeting in Berlin in 2017.5 Utilizing data from this pilot study, we now aim to perform a multi-centre study with sufficient power to determine whether it is feasible to identify a high risk group of patients with lower limb trauma requiring immobilisation who will benefit from thromboprophylaxis The POT-CAST study determined that the rate of venous thrombo-embolism (VTE) in patients with lower limb trauma requiring a cast was 1.8%. This low rate does not justify VTE prophylaxis for all patients who require a cast. However there may be a high risk group with a rate of VTE high enough to suggest that consideration of VTE prophylaxis may be appropriate. This study will prospectively gather risk factor data on patients at the time of initial presentation post trauma with follow up at 12 weeks to identify those patients who have experienced a symptomatic VTE episode. This data will then be used to identify a group with a high VTE risk which future studies can utilise to target this high risk group to assess if VTE prophylaxis is of benefit.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
\-
18 Years
ALL
Yes
Sponsors
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University of Limerick
OTHER
Responsible Party
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Denis O'Keeffe
Consultant Haematologist
Principal Investigators
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denis okeeffe, MBBCH
Role: PRINCIPAL_INVESTIGATOR
University of Limerick
Locations
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Denis OKeeffe
Limerick, , Ireland
Countries
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Central Contacts
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Facility Contacts
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References
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van Adrichem RA, Nemeth B, Algra A, le Cessie S, Rosendaal FR, Schipper IB, Nelissen RGHH, Cannegieter SC; POT-KAST and POT-CAST Group. Thromboprophylaxis after Knee Arthroscopy and Lower-Leg Casting. N Engl J Med. 2017 Feb 9;376(6):515-525. doi: 10.1056/NEJMoa1613303. Epub 2016 Dec 3.
Guyatt GH, Akl EA, Crowther M, Schunemann HJ, Gutterman DD, Lewis SZ. Introduction to the ninth edition: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):48S-52S. doi: 10.1378/chest.11-2286.
Nemeth B, van Adrichem RA, van Hylckama Vlieg A, Bucciarelli P, Martinelli I, Baglin T, Rosendaal FR, le Cessie S, Cannegieter SC. Venous Thrombosis Risk after Cast Immobilization of the Lower Extremity: Derivation and Validation of a Clinical Prediction Score, L-TRiP(cast), in Three Population-Based Case-Control Studies. PLoS Med. 2015 Nov 10;12(11):e1001899; discussion e1001899. doi: 10.1371/journal.pmed.1001899. eCollection 2015 Nov.
Ocak G, Vossen CY, Verduijn M, Dekker FW, Rosendaal FR, Cannegieter SC, Lijfering WM. Risk of venous thrombosis in patients with major illnesses: results from the MEGA study. J Thromb Haemost. 2013 Jan;11(1):116-23. doi: 10.1111/jth.12043.
Other Identifiers
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TILLIRI
Identifier Type: -
Identifier Source: org_study_id