Efficacy and safety of tranexamic acid administration in traumatic brain injury patients: a systematic review and meta-analysis

Shoji Yokobori, Tomoaki Yatabe, Yutaka Kondo, Kosaku Kinoshita, Japan Resuscitation Council (JRC) Neuroresuscitation Task Force and the Guidelines Editorial Committee, Yasuhiko Ajimi, Masaaki Iwase, Kyoko Unemoto, Junji Kumasawa, Jun Goto, Hitoshi Kobata, Atsushi Sawamura, Toru Hifumi, Eisei Hoshiyama, Mitsuru Honda, Yasuhiro Norisue, Shoji Matsumoto, Yasufumi Miyake, Takashi Moriya, Hideto Yasuda, Kazuma Yamakawa, Sunghoon Yang, Masahiro Wakasugi, Masao Nagayama, Hiroshi Nonogi, Shoji Yokobori, Tomoaki Yatabe, Yutaka Kondo, Kosaku Kinoshita, Japan Resuscitation Council (JRC) Neuroresuscitation Task Force and the Guidelines Editorial Committee, Yasuhiko Ajimi, Masaaki Iwase, Kyoko Unemoto, Junji Kumasawa, Jun Goto, Hitoshi Kobata, Atsushi Sawamura, Toru Hifumi, Eisei Hoshiyama, Mitsuru Honda, Yasuhiro Norisue, Shoji Matsumoto, Yasufumi Miyake, Takashi Moriya, Hideto Yasuda, Kazuma Yamakawa, Sunghoon Yang, Masahiro Wakasugi, Masao Nagayama, Hiroshi Nonogi

Abstract

Background: The exacerbation of intracranial bleeding is critical in traumatic brain injury (TBI) patients. Tranexamic acid (TXA) has been used to improve outcomes in TBI patient. However, the effectiveness of TXA treatment remains unclear. This study aimed to assess the effect of administration of TXA on clinical outcomes in patients with TBI by systematically reviewing the literature and synthesizing evidence of randomized controlled trials (RCTs).

Methods: MEDLINE, the Cochrane Central Register of Controlled Trials, and Igaku Chuo Zasshi (ICHUSHI) Web were searched. Selection criteria included randomized controlled trials with clinical outcomes of adult TBI patients administered TXA or placebo within 24 h after admission. Two investigators independently screened citations and conducted data extraction. The primary "critical" outcome was all-cause mortality. The secondary "important" outcomes were good neurological outcome rates, enlargement of bleeding, incidence of ischemia, and hemorrhagic intracranial complications. Random effect estimators with weights calculated by the inverse variance method were used to report risk ratios (RRs).

Results: A total of 640 records were screened. Seven studies were included for quantitative analysis. Of 10,044 patients from seven of the included studies, 5076 were randomly assigned to the TXA treatment group, and 4968 were assigned to placebo. In the TXA treatment group, 914 patients (18.0%) died, while 961 patients (19.3%) died in the placebo group. There was no significant difference between groups (RR, 0.93; 95% confidence interval, 0.86-1.01). No significant differences between the groups in other important outcomes were also observed.

Conclusions: TXA treatment demonstrated a tendency to reduce head trauma-related deaths in the TBI population, with no significant incidence of thromboembolic events. TXA treatment may therefore be suggested in the initial TBI care.

Keywords: Clotting; Fibrinolysis; Head-trauma; Hematoma; Hemorrhage; Meta-analysis; TBI.

Conflict of interest statement

Competing interestsThe authors declare no conflicts of interest.

© The Author(s) 2020.

Figures

Fig. 1
Fig. 1
Flow chart of the search strategy and study selection
Fig. 2
Fig. 2
Forest plot comparing the all-cause mortality values between the tranexamic acid and placebo groups. Risk of bias summary is listed as follows: a, random sequence generation (selection bias); b, allocation concealment (selection bias); c, blinding of participants and personnel (performance bias); d, blinding of outcome assessment (detection bias); e, incomplete outcome data (attrition bias); f, selective reporting (reporting bias); and g, other bias. TXA, tranexamic acid; CI, confidence interval
Fig. 3
Fig. 3
Forest plot comparing poor neurological outcome rates between the tranexamic acid and placebo groups. Risk of bias summary is listed as follows: a, random sequence generation (selection bias); b, allocation concealment (selection bias); c, blinding of participants and personnel (performance bias); d, blinding of outcome assessment (detection bias); e, incomplete outcome data (attrition bias); f, selective reporting (reporting bias); and g, other bias. TXA, tranexamic acid; CI, confidence interval
Fig. 4
Fig. 4
Forest plot comparing the incidence of ischemic or thromboembolic complications between the tranexamic acid and placebo-control groups. Risk of bias summary is listed as follows: a, random sequence generation (selection bias); b, allocation concealment (selection bias); c, blinding of participants and personnel (performance bias); d, blinding of outcome assessment (detection bias); e, incomplete outcome data (attrition bias); f, selective reporting (reporting bias); and g, other bias. TXA, tranexamic acid; CI, confidence interval
Fig. 5
Fig. 5
Forest plot comparing the incidence of hemorrhagic complications between the tranexamic acid and control groups. Risk of bias summary is listed as follows: a, random sequence generation (selection bias); b, allocation concealment (selection bias); c, blinding of participants and personnel (performance bias); d, blinding of outcome assessment (detection bias); e, incomplete outcome data (attrition bias); f, selective reporting (reporting bias); and g, other bias. TXA, tranexamic acid; CI, confidence interval

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Source: PubMed

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