Biomarkers in MCS (BIOMiCS)
Research type
Research Study
Full title
Identification of optimal markers to assess bleeding and thrombosis risk in patients on mechanical circulatory support
IRAS ID
345732
Contact name
Diana Gorog
Contact email
Sponsor organisation
Royal Brompton and Harefielld Hospitals, Guy's and St Thomas' NHS Foundation Trust
Clinicaltrials.gov Identifier
not applicable, not applicable
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Patients who suddenly develop a very weak heart can be treated temporarily with a heart pump, to support the work of the heart to pump blood around the body. Patients receiving heart pump support are treated with blood thinning medications to prevent blood in the heart pump from clotting. However despite this, patients on heart pumps are at high risk of life-threatening complications, including major bleeding and also clotting events (where an artery is blocked by a clot causing a stroke and heart attack). Although conventional blood tests to check clotting are frequently done during pump support, clotting and bleeding complications still occur very frequently and there are no optimal methods to identify which patients are at the greatest risk of clotting or bleeding.
We propose to undertake a prospective observational cohort study in patients treated with heart pump support. We will use test blood samples taken while the patient is treated with a heart pump, to assess novel blood markers of bleeding and clotting. Additional research blood samples will be taken just before the heart pump is started (when possible), twice daily for the first 72 hours, and then daily thereafter. An extra blood sample will be taken as close as possible to the occurrence of any major clotting or bleeding event and once the patient no longer needs the heart pump.
Patients will be reviewed daily while in the hospital, and then after discharge, at 1 month, 3 months, and 1 year through telephone consultations and access to electronic health records. We will inquire whether any bleeding or clotting events have occurred. We aim to identify novel markers of clotting and bleeding, which may allow us to predict which patients are likely to have complications, so we can adjust blood thinning medications to minimise these complications in the future.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
24/LO/0805
Date of REC Opinion
18 Dec 2024
REC opinion
Further Information Favourable Opinion