ATN-108
Research type
Research Study
Full title
Phase 3, double-blind, placebo-controlled, multicentre study on the efficacy and safety of human plasma derived antithrombin (Atenativ) in heparin-resistant patients scheduled to undergo cardiac surgery necessitating cardiopulmonary bypass.
IRAS ID
1009957
Contact name
Kirsty Davies
Contact email
Sponsor organisation
Octapharma AG
Eudract number
2023-507560-39
ISRCTN Number
ISRCTN55521313
Clinicaltrials.gov Identifier
Research summary
The study evaluates how well different doses of the drug, Atenativ work to restore and maintain participants’ responsiveness to another drug called heparin. Heparin is given during cardiac surgery to prevent blood from clotting whilst on a heart and lung machine.
The study will include men and women, 18-85 years old who require cardiac surgery using a heart and lung machine and who are found to be ‘heparin resistant’.
Patients who consent to the study and are ‘heparin resistant’ will be randomised (allocated by chance) in to one of three groups; 1) Atenativ at a dose of 15 International Units per kilogram body weight, 2) Atenativ at a dose of 30 International Units per kilogram body weight; 3) Placebo (a liquid that looks like the study drug but contains no medicine). Participants will be treated as per their allocated treatment group alongside usual treatment required for cardiac surgery. During surgery, blood samples will be taken at predetermined time points to monitor levels of a compound known as ‘antithrombin’ and blood cell levels.
In addition to the expected hospital visits for cardiac surgery patients, participants will receive a final phone call 28 days after their procedure when they will be asked about their health. The time from consenting to the study until the final phone call will be between 28-35 days.
Some risks are associated with taking part, as sometimes, people receiving medications made from human blood plasma, such as Atenativ, have allergic/hypersensitivity reactions.
Taking part in this study may not result in personal medical benefit however the knowledge gained may benefit future patients.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0183
Date of REC Opinion
15 Oct 2024
REC opinion
Further Information Favourable Opinion