DVT after cardiac procedure

  • Research type

    Research Study

  • Full title

    Is Deep Vein Thrombosis an Under-recognised Complication of Electrophysiology Procedures? A Mechanistic Observational Study Investigating Markers and Incidence of Thromboembolism.

  • IRAS ID

    219270

  • Contact name

    Gwilym Morris

  • Contact email

    gwilym.morris@manchester.ac.uk

  • Sponsor organisation

    Central Manchester University Hospital NHS Foundation Trust

  • Duration of Study in the UK

    0 years, 10 months, 31 days

  • Research summary

    Research Summary:
    Electrophysiological study (EPS) and catheter ablation is an established method for the assessment and treatment of many patients with cardiac arrhythmias (altered heart rhythm). It is generally carried out in patients who are usually otherwise fairly fit and healthy. In the UK many patients undergo this procedure and the numbers are increasing. The procedure involves a number of catheters (tubes) being inserted into the femoral vein over a period of up to 2 ½ hours. Presence of the catheter in the vein increases the risk of blood clot formation, if a clot blocks a deep vein in the leg (deep vein thrombosis), it can lead to pain and chronic leg swelling as well as the need for blood thinning (anticoagulant) medications. In some patients, fragments of the blood clot can break off and travel to the lungs which can be life-threatening. It is important to detect the presence of a clot as soon as possible, so that treatment may be given. We hope to establish if the condition is more common than originally thought.

    We plan to recruit 100 patients who are due to undergo EPS or catheter ablation. Prior to their clinical procedure, we will perform an additional blood test to check blood clotting function. After the cardiac procedure, the participants will then undergo Doppler ultrasound scans at 24 hours and a second scan between 10-14 days to check for the presence of blood clots.

    The aim of the study is to increase our understanding of how often these blood clots occur and confirm if blood tests or current gold-standard imaging is best at showing the early stages of blood clot formation. The results of the study will help decide if a clinical trial is needed to test whether giving preventative blood thinning treatment after cardiac procedures would be beneficial.

    Summary of Results:
    Deep Vein Thrombosis (DVT) is common after ablation procedures for "SVT", a common heart rhythm disorder. While this study was to look at how it occurred rather than treatment, doctors performing these procedures should think about whether DVT prophylaxis should be considered in their patients.

  • REC name

    Yorkshire & The Humber - Leeds East Research Ethics Committee

  • REC reference

    17/YH/0344

  • Date of REC Opinion

    2 Oct 2017

  • REC opinion

    Favourable Opinion