Lower Limb Injury Clinical Trial
— TILLIRIOfficial title:
A Prospective Multicentre Study to Assess the Risk Factors That Contribute to Thrombosis in Patients With Lower Limb Injuries (R)Requiring Immobilisation to Identify High Risk Patients Requiring Thromboprophylaxis.
NCT number | NCT04608591 |
Other study ID # | TILLIRI |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2018 |
Est. completion date | December 1, 2023 |
- This study is aimed at identifying patients at high risk for Venous Thrombo-Embolism (VTE) (clots in the veins of legs or clots in the lungs) who have lower limb injuries treated with immobilisation of the lower limb. The study aims to identify high risk patients, who may benefit from thromboprophylaxis (blood thinning medication) to prevent such clots forming. - 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.
Status | Recruiting |
Enrollment | 3500 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients who present to the Emergency Department with lower limb trauma requiring lower limb immobilisation. Aged over 18 Exclusion Criteria: Patient unable to give consent Previous Venous thromboembolism - |
Country | Name | City | State |
---|---|---|---|
Ireland | Denis OKeeffe | Limerick |
Lead Sponsor | Collaborator |
---|---|
University of Limerick |
Ireland,
Guyatt GH, Akl EA, Crowther M, Schünemann 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To measure the number of patients who develop venous thromboembolism within a 12 week period after a lower limb injury requiring immobilisation | All patients who present to the emergency department with lower limb injury ,require lower limb immobilisation and consent to the study will be enrolled in the study. At 12 weeks we will measure the number of patients who have developed a symptomatic venous thromboembolism confirmed by scanning to measure the rate of VTE in this population group. | 12 weeks post trauma and lower limb immobilisation | |
Primary | The identification and measurement of the risk factors that contribute to the development of venous thromboembolism in patients with lower limb injury requiring immobilisation | To record in each participant individual thrombosis risk factors based on the Multiple Environmental and Genetic Assessment of risk factors for venous thrombosis study ( MEGA study) . To identify which of these factors are significantly associated with the development of venous thromboembolism in this population group. | 12 weeks post trauma and immobilisation | |
Secondary | To identify a high risk group that will benefit from chemical prophylaxis | To combine the individual measured risk factors to develop a score that will identify a group of participants who are at high risk of thrombosis and will benefit from chemical prophylaxis | 12 weeks post trauma and immobilisation |
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