TISORB
Research type
Research Study
Full title
Prospective, Open, Multi-center, Single-arm Study to Demonstrate the Feasibility of the CytoSorb 300 mL Device to Remove Ticagrelor During Cardiopulmonary Bypass in Patients on Ticagrelor Undergoing Emergent Cardiothoracic Surgery
IRAS ID
264064
Contact name
Tom Clutton-Brock
Contact email
Sponsor organisation
CytoSorbents Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
Ticagrelor is an anti-platelet drug prescribed to patients at risk of heart disease, it works to thin the blood to prevent clotting. Since Ticagrelor reduces blood clotting, it may also increase bleeding, posing an increased risk if emergency surgery is required. However, some patients on Ticagrelor may develop acute coronary syndrome (a significant blockage in the blood vessels supplying the heart) and need emergency heart surgery before Ticagrelor can be eliminated from the body. These patients may bleed more than expected during and after heart surgery, and this bleeding can cause additional problems for these patients. This study will evaluate a medical device (CytoSorb) which acts to adsorb Ticagrelor from blood during heart surgery. Blood flow is diverted from the patient and through the CytoSorb device which removes the Ticagrelor from the blood before being returned to the patient. This study will determine how well CytoSorb removes Ticagrelor by measuring how well the blood clots before and after using CytoSorb. It is anticipated that 5 UK sites will enroll 30 patients into the study.
REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0060
Date of REC Opinion
4 Jun 2019
REC opinion
Further Information Favourable Opinion