Esmaeil Fakharian1, Masoumeh Abedzadeh-Kalahroudi2, Fatemeh Atoof1. 1. Trauma Research Center, Kashan University of Medical Sciences, Kashan, Iran. 2. Trauma Research Center, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: Abedzadeh@kaums.ac.ir.
Abstract
BACKGROUND:Intracranial hemorrhage is a common complication of traumatic brain injury (TBI). The purpose of this study is evaluation of the effect of tranexamic acid (TXA) on hemorrhagic mass growth in TBI patients. PATIENTS AND METHODS: In this randomized, double-blind clinical trial, 149 patients with TBI and any kind of blood on their computed tomography scan enrolled in the study and were randomly allocated to receive TXA or placebo. After 24 hours, computed tomography scan was repeated for assessing the changes in hemorrhage, new bleeding, and mass effects of blood on brain tissue. The primary outcome was growth of the hemorrhagic lesion. Data were analyzed by SPSS software using Fisher exact, chi-square, and Mann-Whitney U tests, as well as linear and logistic regression models. FINDINGS: The incidence of hemorrhagic lesion growth was 20.5% in the TXA group and 22.7% in the placebo group. The difference was not significant (P = 0.87, RR = 0.89). The mean (standard deviation) of hemorrhagic lesion growth was 9.4 (15.3) in the TXA group and 10.2 (10.1) in the placebo group without significant difference (P = 0.27). The frequency of deaths (2.7% vs. 4%), adverse outcome at discharge (10.8% vs. 17.3%), and 3 months later (6.8% vs. 14.7%) in the TXA group were lower than the placebo, but the difference was not statistically significant. No side effect was observed with the administration of TXA. CONCLUSION: Administration of a short dose of TXA does not lead to significant prevention of growth of posttraumatic hemorrhagic lesion or improvement of clinical outcomes.
RCT Entities:
BACKGROUND:Intracranial hemorrhage is a common complication of traumatic brain injury (TBI). The purpose of this study is evaluation of the effect of tranexamic acid (TXA) on hemorrhagic mass growth in TBIpatients. PATIENTS AND METHODS: In this randomized, double-blind clinical trial, 149 patients with TBI and any kind of blood on their computed tomography scan enrolled in the study and were randomly allocated to receive TXA or placebo. After 24 hours, computed tomography scan was repeated for assessing the changes in hemorrhage, new bleeding, and mass effects of blood on brain tissue. The primary outcome was growth of the hemorrhagic lesion. Data were analyzed by SPSS software using Fisher exact, chi-square, and Mann-Whitney U tests, as well as linear and logistic regression models. FINDINGS: The incidence of hemorrhagic lesion growth was 20.5% in the TXA group and 22.7% in the placebo group. The difference was not significant (P = 0.87, RR = 0.89). The mean (standard deviation) of hemorrhagic lesion growth was 9.4 (15.3) in the TXA group and 10.2 (10.1) in the placebo group without significant difference (P = 0.27). The frequency of deaths (2.7% vs. 4%), adverse outcome at discharge (10.8% vs. 17.3%), and 3 months later (6.8% vs. 14.7%) in the TXA group were lower than the placebo, but the difference was not statistically significant. No side effect was observed with the administration of TXA. CONCLUSION: Administration of a short dose of TXA does not lead to significant prevention of growth of posttraumatic hemorrhagic lesion or improvement of clinical outcomes.
Authors: Andrew M Demchuk; Patrick Yue; Elena Zotova; Juliet Nakamya; Lizhen Xu; Truman J Milling; Tomoyuki Ohara; Joshua N Goldstein; Saskia Middeldorp; Peter Verhamme; Jose Luis Lopez-Sendon; Pamela B Conley; John T Curnutte; John W Eikelboom; Mark Crowther; Stuart J Connolly Journal: Stroke Date: 2021-05-10 Impact factor: 10.170
Authors: Abda Mahmood; Kelly Needham; Haleema Shakur-Still; Tim Harris; Sabariah Faizah Jamaluddin; David Davies; Antonio Belli; Fatahul Laham Mohamed; Caroline Leech; Hamzah Mohd Lotfi; Phil Moss; Fiona Lecky; Philip Hopkins; Darin Wong; Adrian Boyle; Mark Wilson; Melanie Darwent; Ian Roberts Journal: Emerg Med J Date: 2020-12-01 Impact factor: 2.740