Lamy, Andre and Sirota, Dmitry A. and Jacques, Frederic and Poostizadeh, Ahmad and Noiseux, Nicolas and Efremov, Sergey and Demers, Philippe and Akselrod, Boris and Wang, Chew Yin and Arora, Rakesh C. and Branny, Piotr and Mcguinness, Shay P. and Brown, Craig D. and Jeanmart, Hugues and Zhao, Qiang and Zhang, Haibo and Belley-Cote, Emilie P. and Whitlock, Richard P. and Browne, Austin and Copland, Ingrid and Vincent, Jessica and Khatun, Rutaba and Balasubramanian, Kumar and Bangdiwala, Shrikant I. and Mcgillion, Michael H. and Fox-Robichaud, Alison E. and Spence, Jessica and Yusuf, Salim and Devereaux, P. J. and Group, DEPOSITION Study (2024) Topical Versus Intravenous Tranexamic Acid in Patients Undergoing Cardiac Surgery: The DEPOSITION Randomized Controlled Trial. Circulation, 150 (17). pp. 1315-1323. ISSN 0009-7322, DOI https://doi.org/10.1161/CIRCULATIONAHA.124.069606.
Full text not available from this repository.Abstract
BACKGROUND:Although intravenous tranexamic acid is used in cardiac surgery to reduce bleeding and transfusion, topical tranexamic acid results in lower plasma concentrations compared with intravenous tranexamic acid, which may lower the risk of seizures. We aimed to determine whether topical tranexamic acid reduces the risk of in-hospital seizure without increasing the risk of transfusion among cardiac surgery patients.METHODS:We conducted a multicenter, double dummy, blinded, randomized controlled trial of patients recruited by convenience sampling in academic hospitals undergoing cardiac surgery with cardiopulmonary bypass. Between September 17, 2019, and November 28, 2023, a total of 3242 patients from 16 hospitals in 6 countries were randomly assigned (1:1 ratio) to receive either intravenous tranexamic acid (control) through surgery or topical tranexamic acid (treatment) at the end of surgery. The primary outcome was seizure, and the secondary outcome was red blood cell transfusion. After the last planned interim analysis, when 75% of anticipated participants had completed follow up, the data and safety monitoring board recommended to terminate the trial, and upon unblinding, the operations committee stopped the trial for safety.RESULTS:Among 3242 randomized patients (mean age, 66.0 years; 77.7% male), in-hospital seizure occurred in 4 of 1624 patients (0.2%) in the topical group, and 11 of 1628 patients (0.7%) in the intravenous group (absolute risk difference, -0.5% 95% CI, -0.9 to 0.03]; P=0.07). Red blood cell transfusion occurred in 570 patients (35.1%) in the topical group and in 433 (26.8%) in the intravenous group (absolute risk difference, 8.3% 95% CI, 5.2-11.5]; P=0.007). The absolute risk difference in transfusion of >= 4 units of red blood cells in the topical group compared with the intravenous group was 8.2% (95% CI, 3.4-12.9).CONCLUSIONS:Among patients undergoing cardiac surgery, topical administration of tranexamic acid resulted in an 8.3% absolute increase in transfusion without reducing the incidence of seizure, compared with intravenous tranexamic acid.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03954314.
| Item Type: | Article |
|---|---|
| Funders: | Canadian Institutes of Health Research (CIHR) (PJT-175075), McMaster Surgical Associates, Population Health Research Institute |
| Uncontrolled Keywords: | administration, intravenous; administration, topical; blood transfusion; seizures; thoracic surgery; tranexamic acid |
| Subjects: | R Medicine > R Medicine (General) |
| Divisions: | Faculty of Medicine > Anaesthesiology Department |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 17 Feb 2025 04:06 |
| Last Modified: | 17 Feb 2025 04:06 |
| URI: | http://eprints.um.edu.my/id/eprint/47410 |
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