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Thromboses, VenousTILLIRINCT04608591

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

An observational study of Thromboses, Venous and Lower Limb Injury, run by University of Limerick at 1 site in Ireland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Thromboses, Venous, Lower Limb Injury
How many people
3,500 participants
Where
1 siteIreland
Study dates
1 Dec 2018to 1 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patient unable to give consent Previous Venous thromboembolism
  • -

Trial locations and contacts

1 site in 1 country.

Denis OKEEFFE, MBBCH contact

00353868049118

denis.okeeffe@hse.ie

Michael Watts, MD contact

00353889865154

Michael.Watts@hse.ie

Ireland1 site, 1 recruiting

  • Denis OKeeffe

    Limerick, V94YVHO

    denis okeeffe, MBBCH, 00353868049118, denis.okeeffe@hse.ie

    michael watts, MD, 00353879865154, Michael.Watts@hse.ie

    Recruiting

Other trials in Ireland

About this study

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.

  • 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.
Read the 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.

Keywords
Venous thromboembolism prophylaxis
Medical subject headings
Venous Thrombosis, Leg Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks post trauma and lower limb immobilisation

  2. 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.

    Measured: 12 weeks post trauma and immobilisation

Secondary outcomes (1)

  1. 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

    Measured: 12 weeks post trauma and immobilisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start1 Dec 2018
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04608591
Sponsor's protocol ID
TILLIRI
Acronym
TILLIRI
Status last verified
Oct 2020
First submitted
19 Oct 2020
Last updated
29 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All researchers will input their centre patient data. The overall committee will review all patient data for review purposes . Individual centres will not be able to access other centres data.

Publications

  • 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.

    PubMed 27959702

  • 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.

    PubMed 22315255

  • 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.

    PubMed 26554832

  • 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.

    PubMed 23106832

Questions about this trial

What is this clinical trial studying?

An observational study of Thromboses, Venous and Lower Limb Injury, run by University of Limerick at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Denis OKEEFFE, MBBCH (00353868049118, denis.okeeffe@hse.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To measure the number of patients who develop venous thromboembolism within a 12 week period after a lower limb injury requiring immobilisation (time frame: 12 weeks post trauma and lower limb immobilisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04608591, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.

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