Clinical trial NCT04608591: A Prospective Study to Assess the Risk Factors That Contribute to Thrombosis in Patients With Lower Limb Injuries.
Official 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thromboses, Venous
Lower Limb Injury
Keywords: Venous thromboembolism prophylaxis
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Currently, there is wide variation in the provision of venous thromboembolism (VTE) prophylaxis for patients who suffer lower limb trauma and require lower limb immobilisation. Current United Kingdom guidelines recommend assessing competing risks of VTE and bleeding followed by shared decision-making with the patient on prescription of pharmacological thromboprophylaxis (VTE thromboprophylaxis). However, current American College of Chest Physicians (ACCP) guidelines do not recommend VTE thromboprophylaxis for this group. The largest study carried out to date, the Prevention of Thrombosis after Lower Leg Plaster Cast (POT-CAST) randomised controlled trial 1 identified a very low rate of VTE (1.8%) in the non-intervention arm. This study concluded that thromboprophylaxis was not justified for patients with lower limb trauma who required lower limb immobilisation. However, it recommended that further studies are required to see if it is possible to identify a high risk cohort of patients who may benefit from VTE thromboprophylaxis. No large prospective study has been published to date to assess if it is possible to identify this high risk group.

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.

Eligibility criteria: 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

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Primary outcomes:
measure: To measure the number of patients who develop venous thromboembolism within a 12 week period after a lower limb injury requiring immobilisation
timeFrame: 12 weeks post trauma and lower limb immobilisation
measure: The identification and measurement of the risk factors that contribute to the development of venous thromboembolism in patients with lower limb injury requiring immobilisation
timeFrame: 12 weeks post trauma and immobilisation
Secondary outcomes:
measure: To identify a high risk group that will benefit from chemical prophylaxis
timeFrame: 12 weeks post trauma and immobilisation
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: Denis OKeeffe
Study officials:
affiliation: University of Limerick
name: denis okeeffe, MBBCH
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.