Study Type
Inteventional - Drug
ongoing
The primary objective of the DEPOSITION study is to determine in patients undergoing on-pump cardiac surgery, if topical tranexamic acid (intra-pericardial) is superior to the usual intravenous tranexamic acid (TxA) administration for reducing the risk of in-hospital seizure. Our secondary objective is to determine in patients undergoing on-pump cardiac surgery, if topical TxA (intra-pericardial) compared with intravenous TxA administration is associated with a non-inferior risk of in-hospital red blood cell transfusion. We are proposing a multi-centre double-dummy, randomized control trial including 3800 cardiac surgery patients.
We successfully completed the DEPOSITION pilot study which included 107 cardiac surgery patients and proved feasibility of our proposed protocol. Subjects will be randomized in a 1:1 ratio to topical TxA (IV placebo + topical TxA) or intravenous TxA (IV TxA + topical placebo). The surgeons, anesthetists, along with research and clinical teams are blinded to the allocation. Patients will be followed in hospital until discharge or 10 days (whichever comes first).
Our vision is to produce strong evidence to support practice change in cardiac surgery toward the use of topical TxA.
About DEPOSITION - Download PDFStudy Design
Double-dummy RCT
NO. of Countries
6
NO. of Sites
16
NO. of Participants
3242
Study Period
2019 - 2023
Sponsor
PHRI
Andre Lamy
Scientist
Andre Lamy
Scientist
Andre Lamy is a cardiac surgeon practicing at the Hamilton Health Sciences since 1996, and Professor in the Department of Surgery, McMaster University. He led the Canadian Institute of Health Research funded CORONARY trial, which evaluated off-pump CABG surgery versus on-pump CABG surgery in 4752 patients. The results were published in the New England Journal of Medicine in 2012 and 2013.
Jessica Vincent
Program Director
Jessica Vincent
Program Director
Jessica Vincent has more than 15 years’ experience in coordinating and managing large, international clinical trials. As Associate Program Manager, she oversees interventional trials, registries, and observational research studies in the areas of perioperative medicine, cardiac surgery, and digital health.
She holds an Honours Bachelor of Science Degree from Queens University, and a Master of Clinical Epidemiology Degree from the University of Newcastle.
Ingrid Copland
Senior Research Coordinator
Ingrid Copland
Senior Research Coordinator
Ingrid Copland has been working in research for McMaster University since 1991. She has been at PHRI for 23 years where she has coordinated large, international, industry and investigator initiated trials. Since 2014 she has been with the perioperative and surgery department coordinating observational, drug and device trials.
Canadian Institutes of Health Research (CIHR)
McMaster MSA 2019-20 grant
PHRI internal grant
completed
DEPOSITION Pilot
Perioperative & Surgery
The DEPOSITION Pilot trial hypothesized that topical intra-pericardial (i.p.) application of Tranexamic Acid (TxA) versus...
