STAR registry
Research type
Research Study
Full title
Safe and Timely Antithrombotic Removal (STAR) Registry: International registry on the use of CytoSorb for removal of antithrombotic agents in the acute hospital setting
IRAS ID
301571
Contact name
Robert Storey
Contact email
Sponsor organisation
CytoSorbents Inc
Duration of Study in the UK
4 years, 1 months, 29 days
Research summary
Some heart conditions are caused by, or increase the risk of, blood clots forming in the heart or blood vessels. Anti-clotting drugs are used in these heart conditions to reduce the risk of blood clots but lead to an increased risk of bleeding, particularly in people who need to undergo open-heart surgery. CytoSorb is a medical device that can be used during open-heart surgery to remove some anti-clotting medications in order to reduce this risk of bleeding. During open-heart surgery, blood is pumped through a heart-lung machine and, at the same time, can also be pumped through the CytoSorb device, which acts like a kind of filter. The device is CE-mark approved in Europe for the removal of two types of routinely-used anti-clotting drug known as ticagrelor and rivaroxaban. CytoSorb treatment has so far been used in more than 130,000 human treatments in more than 800 clinical departments around the world. Approximately 10% of the devices have been used for intra-operative treatments requiring heart-lung machine (cardiopulmonary bypass). The treatment is considered safe but more information is required about the circumstances in which it is used in routine care and what happens to people who receive this treatment.
The STAR registry is an international study that is collecting information about patients who receive treatment with the CytoSorb device as part of their routine heart surgery. The purpose of the study is to gain more information about the effects of the CytoSorb device in routine clinical care and the circumstances in which it is used. The study plans to enrol a total of 500 patients at around 30 sites worldwide, including at least 5 hospitals across the United Kingdom. Participation in the registry will not influence the treatment that patients receive.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0163
Date of REC Opinion
9 Aug 2021
REC opinion
Favourable Opinion