Avr Thrombosis OutcoMe study (ATOM)
Can thrombosis and fibrinolysis markers in patients undergoing aortic valve replacement predict outcome
East and North Hertfordshire NHS Trust
Duration of Study in the UK
8 years, 0 months, 0 days
Severe narrowing of the aortic valve (termed aortic stenosis), is a condition that usually requires valve replacement. This valve can be metallic, or tissue, with the later composed of synthetic and biological material.
Recent studies have demonstrated that about 10% of patients develop blood clots on tissue valve replacements, which can increase the risk of stroke and also the rate of degeneration of the valve. Administering blood thinners to all patients to prevent clot development seems a logical solution, but this resulted in significant bleeding in a recent study.
Identifying which patients are at risk of clot development would be important so that these patients can be selectively treated with blood thinners.
We propose performing novel blood tests to assess the stickiness of blood to help identify patients at risk of either clot development or bleeding.
This novel blood test has already been used by our hospital to identify those patients at highest risk after a heart attack. We therefore hope this blood test can add value in the management of this new cohort of patients with replaced aortic valves.
Blood tests will be performed before and after the valve replacement operation, and we shall follow patients up for 5 years to document the occurrence of heart attacks, strokes, or valve problems, including clot development on the valve. In addition, in a subset of patients, two additional heart CT scans will be performed at 3-6 months and 1 year after the valve replacement, to identify any clots on the valve replacement or any early degeneration of the valve, and this will be correlated with the results of the blood tests.
Patients will be recruited from both the Royal Brompton and Harefield NHS Trust and East and North Hertfordshire NHS Trust.
London - Fulham Research Ethics Committee
Date of REC Opinion
29 May 2019