A Prospective Study to Assess the Risk Factors That Contribute to Thrombosis in Patients With Lower Limb Injuries.

NCT04608591 | Unknown

• 1 other identifier: TILLIRI
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Thromboses, Venous; Lower Limb Injury

Keywords

Venous thromboembolism prophylaxis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• To identify a high risk group that will benefit from chemical prophylaxis

  12 weeks post trauma and immobilisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who present to the Emergency Departments of participating centres with lower limb injury over 18 requiring lower limb immobilisation.

You may qualify if:

• All patients who present to the Emergency Department with lower limb trauma requiring lower limb immobilisation. Aged over 18

You may not qualify if:

• Patient unable to give consent Previous Venous thromboembolism

Sponsors & Collaborators

• University of Limerick: lead

Study Sites (1)

Denis OKeeffe

Limerick, V94YVHO, Ireland

RECRUITING

Related Publications (4)

• 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.

  PMID: 27959702 BACKGROUND

• 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.

  PMID: 22315255 BACKGROUND

• 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.

  PMID: 26554832 BACKGROUND

• 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.

  PMID: 23106832 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis; Leg Injuries

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Officials

• denis okeeffe, MBBCH

  University of Limerick

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denis OKEEFFE, MBBCH

CONTACT

00353868049118; denis.okeeffe@hse.ie

Michael Watts, MD

CONTACT

00353889865154; Michael.Watts@hse.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Haematologist

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 29, 2020
• Study Start: December 1, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At the end of trial for a limited time.
• Access Criteria: Only the reviewing committee will have access to all data. Individual centres will have access to their centres data.

Locations

IE (1)