@article{e748d6b64af5488397e1fa6b6ec562f6,
title = "The risk of thromboembolic events with early intravenous 2- and 4-g bolus dosing of tranexamic acid compared to placebo in patients with severe traumatic bleeding: A secondary analysis of a randomized, double-blind, placebo-controlled, single-center trial",
abstract = "Background: Screening for the risk of thromboembolism (TE) due to tranexamic acid (TXA) in patients with severe traumatic injury has not been performed in randomized clinical trials. Our objective was to determine if TXA dose was independently-associated with thromboembolism. Study Design and Methods: This is a secondary analysis of a single-center, double-blinded, randomized controlled trial comparing placebo to a 2-g or 4-g intravenous TXA bolus dose in trauma patients with severe injury. We used multivariable discrete-time Cox regression models to identify associations with risk for thromboembolic events within 30 days post-enrollment. Event curves were created using discrete-time Cox regression. Results: There were 50 patients in the placebo group, 49 in the 2-g, and 50 in the 4-g TXA group. In adjusted analyses for thromboembolism, a 2-g dose of TXA had an hazard ratio (HR, 95% confidence interval [CI]) of 3.20 (1.12–9.11) (p =.029), and a 4-g dose of TXA had an HR (95% CI) of 5.33 (1.94–14.63) (p =.001). Event curves demonstrated a higher probability of thromboembolism for both doses of TXA compared to placebo. Other parameters independently associated with thromboembolism include time from injury to TXA administration, body mass index, and total blood products transfused. Discussion: In patients with severe traumatic injury, there was a dose-dependent increase in the risk of at least one thromboembolic event with TXA. TXA should not be withheld, but thromboembolism screening should be considered for patients receiving a dose of at least 2-g TXA intravenously for traumatic hemorrhage.",
keywords = "clinical trial, thromboembolism, tranexamic acid, trauma",
author = "Spinella, {Philip C.} and Kelly Bochicchio and Thomas, {Kimberly A.} and Amanda Staudt and Shea, {Susan M.} and Pusateri, {Anthony E.} and Douglas Schuerer and Levy, {Jerrold H.} and Cap, {Andrew P.} and Grant Bochicchio",
note = "Funding Information: This study was funded by the U.S. Department of Defense, U.S. Army Medical Research and Materiel Command (Award W81XWH‐14‐1‐0373), the Department of Surgery at Washington University in St Louis, St Louis, MO, the Department of Pediatrics, Washington University in St Louis, St Louis, MO, and by the US Army Institute of Surgical Research at Joint Base San Antonio‐Fort Sam Houston, TX. The US Department of Defense had a role in the study design, collection, analysis, interpretation of the data, writing the report, and deciding where to submit the manuscript for publication. The TAMPITI trial investigators that contributed to the implementation of the trial include; Obeid Ilahi, MD; Stephen Jarman, RN, BSN; John Kirby, MD; Tiffany Osborn, MD, MPH; Bryan Sato, RN, BSN; Eden Nohra, MD; Laurie Punch, MD; Jarot Guerra, MD; Maya Sorini, BS; James McMullen, BS; Nicholas Fiore, BS; Rohit Rasane, MBBS; Brendan Wesp, BS; Jason Snyder, MD; Qiao Zhang, MS; Shin‐Wen Hughes, BS; Sarbani Ghosh, MHS, Adrian Coleoglou Centeno, MD; Christopher Horn, MD, Isaiah R. Turnbull, MD, PhD. The authors would also like to acknowledge Jessica Smith, MD, who served as the Research Monitor, as well as the Data and Safety Monitoring Board members: Enyo Ablordeppey, MD, MPH, James Fehr, MD, Philip Miller, George Despotis, MD, Melanie Fields, MD, and Kevin Ward, MD. Funding Information: This study was funded by the U.S. Department of Defense, U.S. Army Medical Research and Materiel Command (Award W81XWH-14-1-0373), the Department of Surgery at Washington University in St Louis, St Louis, MO, the Department of Pediatrics, Washington University in St Louis, St Louis, MO, and by the US Army Institute of Surgical Research at Joint Base San Antonio-Fort Sam Houston, TX. The US Department of Defense had a role in the study design, collection, analysis, interpretation of the data, writing the report, and deciding where to submit the manuscript for publication. The TAMPITI trial investigators that contributed to the implementation of the trial include; Obeid Ilahi, MD; Stephen Jarman, RN, BSN; John Kirby, MD; Tiffany Osborn, MD, MPH; Bryan Sato, RN, BSN; Eden Nohra, MD; Laurie Punch, MD; Jarot Guerra, MD; Maya Sorini, BS; James McMullen, BS; Nicholas Fiore, BS; Rohit Rasane, MBBS; Brendan Wesp, BS; Jason Snyder, MD; Qiao Zhang, MS; Shin-Wen Hughes, BS; Sarbani Ghosh, MHS, Adrian Coleoglou Centeno, MD; Christopher Horn, MD, Isaiah R. Turnbull, MD, PhD. The authors would also like to acknowledge Jessica Smith, MD, who served as the Research Monitor, as well as the Data and Safety Monitoring Board members: Enyo Ablordeppey, MD, MPH, James Fehr, MD, Philip Miller, George Despotis, MD, Melanie Fields, MD, and Kevin Ward, MD. Publisher Copyright: {\textcopyright} 2022 AABB.",
year = "2022",
month = aug,
doi = "10.1111/trf.16962",
language = "English",
volume = "62",
pages = "S139--S150",
journal = "Transfusion",
issn = "0041-1132",
number = "S1",
}