TY - JOUR
T1 - Does tranexamic acid increase venous thromboembolism risk among trauma patients? A prospective multicenter analysis across 17 level I trauma centers
AU - Knowlton, Lisa Marie
AU - Arnow, Katherine
AU - Trickey, Amber W.
AU - Sauaia, Angela
AU - Knudson, M. Margaret
N1 - Funding Information:
The US Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick , MD 21702–5014 , is the awarding and administering acquisition office. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Defense Medical Research and Development Program under award number W81XWH-17–1–0673 . Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense .
Funding Information:
We analyzed prospectively collected observational data from the Consortium of Leaders in the Study of Traumatic Thromboembolism (CLOTT) dataset. CLOTT 1 was a multicenter study conducted across 17 major trauma centers in the United States, studying venous thromboembolism (VTE) in trauma [6] . The original CLOTT study was funded by the Department of Defense and approved by the US Department of Defense Human Research Protection Office. The institutional review boards at all centers approved the study including waiver of consent because of the observational nature of the study. Full study design details have been previously published [6] . The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guidelines have been followed for this and other CLOTT studies.
Funding Information:
The US Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702–5014, is the awarding and administering acquisition office. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Defense Medical Research and Development Program under award number W81XWH-17–1–0673. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. Members of the CLOTT Research Group are as follows: M. Margaret Knudson, MD; Ernest E. Moore, MD; Lucy Z. Kornblith, MD; Scott Brakenridge, MD; Sherry L. Sixta, MD; Brandon R. Bruns, MD; Thomas M. Scalea, MD; Todd W. Costantini, MD; Bruce A. Crookes, MD; Elliott R. Haut, MD, PhD; George C. Velmahos, MD; Andrew Kerwin, MD; Alicia Mohr, MD; Lazio N. Kiraly, MD; David A. Spain, MD; Lisa M. Knowlton, MD; Matthew J. Martin, MD; David J Milia, MD; Ram Nirula, MD; Frederick B. Rogers, MD; Charles E. Wade, PhD; Michelle K. McNutt, MD; Mark D. Cipolle, MD.
Publisher Copyright:
© 2023
PY - 2023/11
Y1 - 2023/11
N2 - Importance: The early use of tranexamic acid (TXA) has demonstrated benefit among some trauma patients in hemorrhagic shock. The association between TXA administration and thromboembolic events (including deep vein thrombosis (DVT), pulmonary embolism (PE) and pulmonary thrombosis (PT)) remains unclear. We aimed to characterize the risk of venous thromboembolism (VTE) subtypes among trauma patients receiving TXA and to determine whether TXA is associated with VTE risk and mortality. Methods: We analyzed a prospective, observational, multicenter cohort data from the Consortium of Leaders in the Study of Traumatic Thromboembolism (CLOTT) study group. The study was conducted across 17 US level I trauma centers between January 1, 2018, and December 31,2020. We studied trauma patients ages 18–40 years, admitted for at least 48 h with a minimum of 1 VTE risk factor and followed until hospital discharge or 30 days. We compared TXA recipients to non-recipients for VTE and mortality using inverse probability weighted Cox models. The primary outcome was the presence of documented venous thromboembolism (VTE). The secondary outcome was mortality. VTE was defined as DVT, PE, or PT. Results: Among the 7,331 trauma patients analyzed, 466 (6.4%) received TXA. Patients in the TXA group were more severely injured than patients in the non-TXA group (ISS 16+: 69.1% vs. 48.5%, p < 0.001) and a higher percentage underwent a major surgical procedure (85.8% vs. 73.6%, p < 0.001). Among TXA recipients, 12.5% developed VTE (1.3% PT, 2.4% PE, 8.8% DVT) with 5.6% mortality. In the non-TXA group, 4.6% developed VTE (1.1% PT, 0.5% PE, 3.0% DVT) with 1.7% mortality. In analyses adjusting for patient demographic and clinical characteristics, TXA administration was not significantly associated with VTE (aHR 1.00, 95%CI: 0.69–1.46, p = 0.99) but was significantly associated with increased mortality (aHR 2.01, 95%CI: 1.46–2.77, p < 0.001). Conclusion: TXA was not clearly identified as an independent risk factor for VTE in adjusted analyses, but the risk of VTE among trauma patients receiving TXA remains high (12.5%). This supports the judicious use of TXA in resuscitation, with consideration of early initiation of DVT prophylaxis in this high-risk group.
AB - Importance: The early use of tranexamic acid (TXA) has demonstrated benefit among some trauma patients in hemorrhagic shock. The association between TXA administration and thromboembolic events (including deep vein thrombosis (DVT), pulmonary embolism (PE) and pulmonary thrombosis (PT)) remains unclear. We aimed to characterize the risk of venous thromboembolism (VTE) subtypes among trauma patients receiving TXA and to determine whether TXA is associated with VTE risk and mortality. Methods: We analyzed a prospective, observational, multicenter cohort data from the Consortium of Leaders in the Study of Traumatic Thromboembolism (CLOTT) study group. The study was conducted across 17 US level I trauma centers between January 1, 2018, and December 31,2020. We studied trauma patients ages 18–40 years, admitted for at least 48 h with a minimum of 1 VTE risk factor and followed until hospital discharge or 30 days. We compared TXA recipients to non-recipients for VTE and mortality using inverse probability weighted Cox models. The primary outcome was the presence of documented venous thromboembolism (VTE). The secondary outcome was mortality. VTE was defined as DVT, PE, or PT. Results: Among the 7,331 trauma patients analyzed, 466 (6.4%) received TXA. Patients in the TXA group were more severely injured than patients in the non-TXA group (ISS 16+: 69.1% vs. 48.5%, p < 0.001) and a higher percentage underwent a major surgical procedure (85.8% vs. 73.6%, p < 0.001). Among TXA recipients, 12.5% developed VTE (1.3% PT, 2.4% PE, 8.8% DVT) with 5.6% mortality. In the non-TXA group, 4.6% developed VTE (1.1% PT, 0.5% PE, 3.0% DVT) with 1.7% mortality. In analyses adjusting for patient demographic and clinical characteristics, TXA administration was not significantly associated with VTE (aHR 1.00, 95%CI: 0.69–1.46, p = 0.99) but was significantly associated with increased mortality (aHR 2.01, 95%CI: 1.46–2.77, p < 0.001). Conclusion: TXA was not clearly identified as an independent risk factor for VTE in adjusted analyses, but the risk of VTE among trauma patients receiving TXA remains high (12.5%). This supports the judicious use of TXA in resuscitation, with consideration of early initiation of DVT prophylaxis in this high-risk group.
KW - Pulmonary thrombosis
KW - Surgical outcomes
KW - Tranexamic acid
KW - Venous thromboembolism
UR - http://www.scopus.com/inward/record.url?scp=85169818509&partnerID=8YFLogxK
U2 - 10.1016/j.injury.2023.111008
DO - 10.1016/j.injury.2023.111008
M3 - Article
C2 - 37669883
AN - SCOPUS:85169818509
SN - 0020-1383
VL - 54
JO - Injury
JF - Injury
IS - 11
M1 - 111008
ER -