Topical Versus Intravenous Tranexamic Acid in Patients Undergoing Cardiac Surgery: The DEPOSITION Randomized Controlled Trial

Lamy A 1 , Sirota DA 2 , Jacques F 3 , Poostizadeh A 4 , Noiseux N 5 , Efremov S 6 Show all authors , Demers P 7 , Akselrod B 8 , Wang CY 9 , Arora RC 10 , Branny P 11 , McGuinness SP 12 , Brown CD 13 , Jeanmart H 14 , Zhao Q 15 , Zhang H 16 , Belley-Côté EP 17 , Whitlock RP 1 , Browne A 18 , Copland I 19 , Vincent J 19 , Khatun R 20 , Balasubramanian K 19 , Bangdiwala SI 21 , McGillion MH 22 , Fox-Robichaud AE 23 , Spence J 24 , Yusuf S 17 , Devereaux PJ 25 , DEPOSITION Study Group

Affiliations 

  • 1 Population Health Research Institute, Hamilton, Canada; Department of Surgery, McMaster University, Hamilton, Canada
  • 2 E. Meshalkin National Medical Research Center, Novosibirsk, Russia
  • 3 Institut Universitaire de cardiologie et de pneumologie de Québec, Université Laval, IUCPQ, Quebec City, Canada
  • 4 Kelowna General Hospital, Kelowna, Canada
  • 5 Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal, Canada
  • 6 Saint Petersburg State University Hospital, Saint Petersburg, Russia
  • 7 Montreal Heart Institute, Montreal, Canada
  • 8 Petrovsky National Centre of Surgery, Moscow, Russia
  • 9 Department of Anaesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
  • 10 Division of Cardiac Surgery, Harrington Heart and Vascular Institute, University of Hospitals, Cleveland, OH; Department of Surgery, Case Western Reserve University, Cleveland, OH
  • 11 Head of Cardiac Surgery Department, Hospital Agel Trinec-Podlesi, Trinec, Czech Republic
  • 12 Auckland City Hospital, Auckland, New Zealand
  • 13 New Brunswick Heart Centre, Saint John, New Brunswick
  • 14 CIUSSS-NIM Hôpital du Sacré-Coeur de Montréal, Montreal, Canada
  • 15 Rujin Hospital, Shanghai, China; Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • 16 Beijing Anzhen Hospital, Beijing, China
  • 17 Population Health Research Institute, Hamilton, Canada; Department of Medicine, McMaster University, Hamilton, Canada
  • 18 Hamilton Health Sciences, General Hospital, Hamilton, Canada
  • 19 Population Health Research Institute, Hamilton, Canada
  • 20 Population Health Research Institute, CANADA
  • 21 Population Health Research Institute, Hamilton, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada
  • 22 Population Health Research Institute, Hamilton, Canada; School of Nursing, McMaster University, Hamilton, Canada
  • 23 Dept of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON Canada
  • 24 Population Health Research Institute, Hamilton, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Department of Anesthesia, McMaster University, Hamilton, Canada
  • 25 Population Health Research Institute, Hamilton, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada; Department of Medicine, McMaster University, Hamilton, Canada
Circulation, 2024 Apr 08.
PMID: 38587333 DOI: 10.1161/CIRCULATIONAHA.124.069606

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 to 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 in 11 of 1628 patients (0.7%) in the intravenous group (absolute risk difference, -0.5%; 95% CI, -0.9 to 0.03; P = .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 to 11.5; P = .007). The absolute risk difference in transfusion of ≥4 units of red blood cells in the topical group compared to the intravenous group was 8.2% (95% CI, 3.4 to 12.9).

CONCLUSIONS: Among patients having cardiac surgery, topical administration of tranexamic acid resulted in an 8.3% absolute increase in transfusion without reducing the incidence of seizure, compared to intravenous tranexamic acid.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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