Tranexamic acid in the management of traumatic brain injury: a systematic review and meta-analysis with trial sequential analysis

ABSTRACT Introduction Traumatic brain injury is a leading cause of death and disability. Tranexamic acid, an antifibrinolytic agent, holds the potential for managing intracranial hemorrhages secondary to traumatic brain injury. However, its efficacy and safety remain subjects of ongoing debate. O...

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Main Authors: Thiago Gebrin, Júlia Pinho Neodini, André Felix Gentil, Eduardo Carvalhal Ribas, Mario Lenza, Arthur Werner Poetscher
Format: Article
Language:English
Published: Instituto Israelita de Ensino e Pesquisa Albert Einstein 2025-03-01
Series:Einstein (São Paulo)
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Online Access:http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1679-45082025000100401&lng=en&tlng=en
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author Thiago Gebrin
Júlia Pinho Neodini
André Felix Gentil
Eduardo Carvalhal Ribas
Mario Lenza
Arthur Werner Poetscher
author_facet Thiago Gebrin
Júlia Pinho Neodini
André Felix Gentil
Eduardo Carvalhal Ribas
Mario Lenza
Arthur Werner Poetscher
author_sort Thiago Gebrin
collection DOAJ
description ABSTRACT Introduction Traumatic brain injury is a leading cause of death and disability. Tranexamic acid, an antifibrinolytic agent, holds the potential for managing intracranial hemorrhages secondary to traumatic brain injury. However, its efficacy and safety remain subjects of ongoing debate. Objective To better clarify the efficacy and safety of tranexamic acid in that context and to evaluate the need for further studies. Methods We conducted a comprehensive search of seven electronic databases, eight study repositories, and tertiary sources between January 2021 and 2022 for randomized controlled trials involving victims of traumatic brain injury aged 15 or older who received tranexamic acid versus placebo or standard care. The primary outcomes were all-cause mortality and hemorrhagic complications during treatment. This review incorporated elements of PRISMA guidelines, Cochrane’s Risk of Bias assessment, and GRADE to assess evidence quality. Sensitivity analyses were also conducted. Results Out of 6,958 references retrieved, 14 of the 17 randomized controlled trials were analyzed, encompassing a total of 15,017 patients. Analyses for all-cause mortality did not reach statistical significance (RR= 0.95, 95%CI= 0.88-1.02 | trial sequential analysis RR= 0.95, 95%CI= 0.87-1.03). However, the analysis of hemorrhagic complications during treatment showed statistical significance for progressive intracranial hemorrhage (RR= 0.82, 95%CI= 0.68-0.99 | trial sequential analysis RR= 0.82, 95%CI= 0.38-1.78). Analyses of secondary outcomes, namely unfavorable neurological outcome and other adverse effects, did not demonstrate statistical significance. Conclusion Tranexamic acid use did not demonstrate efficacy based on all-cause mortality but showed a favorable safety profile. Additional clinical trials may shed light on remaining clinical uncertainties. Prospero database registration: CRD42021221949.
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spelling doaj-art-0d2fd34460c64db8a7f4c960d20490b62025-08-20T02:46:29ZengInstituto Israelita de Ensino e Pesquisa Albert EinsteinEinstein (São Paulo)2317-63852025-03-012310.31744/einstein_journal/2025rw0753Tranexamic acid in the management of traumatic brain injury: a systematic review and meta-analysis with trial sequential analysisThiago Gebrinhttps://orcid.org/0000-0002-5145-8869Júlia Pinho Neodinihttps://orcid.org/0009-0000-0203-5758André Felix Gentilhttps://orcid.org/0000-0002-5228-2033Eduardo Carvalhal Ribashttps://orcid.org/0000-0003-3054-5661Mario Lenzahttps://orcid.org/0000-0003-3497-2206Arthur Werner Poetscherhttps://orcid.org/0000-0002-3262-9378ABSTRACT Introduction Traumatic brain injury is a leading cause of death and disability. Tranexamic acid, an antifibrinolytic agent, holds the potential for managing intracranial hemorrhages secondary to traumatic brain injury. However, its efficacy and safety remain subjects of ongoing debate. Objective To better clarify the efficacy and safety of tranexamic acid in that context and to evaluate the need for further studies. Methods We conducted a comprehensive search of seven electronic databases, eight study repositories, and tertiary sources between January 2021 and 2022 for randomized controlled trials involving victims of traumatic brain injury aged 15 or older who received tranexamic acid versus placebo or standard care. The primary outcomes were all-cause mortality and hemorrhagic complications during treatment. This review incorporated elements of PRISMA guidelines, Cochrane’s Risk of Bias assessment, and GRADE to assess evidence quality. Sensitivity analyses were also conducted. Results Out of 6,958 references retrieved, 14 of the 17 randomized controlled trials were analyzed, encompassing a total of 15,017 patients. Analyses for all-cause mortality did not reach statistical significance (RR= 0.95, 95%CI= 0.88-1.02 | trial sequential analysis RR= 0.95, 95%CI= 0.87-1.03). However, the analysis of hemorrhagic complications during treatment showed statistical significance for progressive intracranial hemorrhage (RR= 0.82, 95%CI= 0.68-0.99 | trial sequential analysis RR= 0.82, 95%CI= 0.38-1.78). Analyses of secondary outcomes, namely unfavorable neurological outcome and other adverse effects, did not demonstrate statistical significance. Conclusion Tranexamic acid use did not demonstrate efficacy based on all-cause mortality but showed a favorable safety profile. Additional clinical trials may shed light on remaining clinical uncertainties. Prospero database registration: CRD42021221949.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1679-45082025000100401&lng=en&tlng=enCentral nervous systemTranexamic acidAntifibrinolytic agentsBrain injuries, traumaticCraniocerebral trauma
spellingShingle Thiago Gebrin
Júlia Pinho Neodini
André Felix Gentil
Eduardo Carvalhal Ribas
Mario Lenza
Arthur Werner Poetscher
Tranexamic acid in the management of traumatic brain injury: a systematic review and meta-analysis with trial sequential analysis
Einstein (São Paulo)
Central nervous system
Tranexamic acid
Antifibrinolytic agents
Brain injuries, traumatic
Craniocerebral trauma
title Tranexamic acid in the management of traumatic brain injury: a systematic review and meta-analysis with trial sequential analysis
title_full Tranexamic acid in the management of traumatic brain injury: a systematic review and meta-analysis with trial sequential analysis
title_fullStr Tranexamic acid in the management of traumatic brain injury: a systematic review and meta-analysis with trial sequential analysis
title_full_unstemmed Tranexamic acid in the management of traumatic brain injury: a systematic review and meta-analysis with trial sequential analysis
title_short Tranexamic acid in the management of traumatic brain injury: a systematic review and meta-analysis with trial sequential analysis
title_sort tranexamic acid in the management of traumatic brain injury a systematic review and meta analysis with trial sequential analysis
topic Central nervous system
Tranexamic acid
Antifibrinolytic agents
Brain injuries, traumatic
Craniocerebral trauma
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1679-45082025000100401&lng=en&tlng=en
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