Benefits of the tranexamic acid in head trauma with no extracranial bleeding: a prospective follow-up of 180 patients
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Tranexamic acid (TXA) is one of the debated therapies in the management of traumatic brain injury (TBI). We conducted this study to evaluate the benefits of TXA in TBI on the mortality and its safety in these patients.
This was a prospective randomized open-label trial including all patients, aged at 18 years or older, hospitalized in the emergency room during a 13-month period, for TBI. After the realization of the body CT scan, the patients were included if they had intracranial bleeding, and were then randomized according to their medical file number to receive or not the TXA. The eligibility criteria were based on the uncertainty principle, patients with significant extracranial bleeding were excluded since there was evidence that TXA improve their outcome.
We enrolled 180 patients aged at 42 ± 20 years, with an 88% men-proportion. Subarachnoid haemorrhage was the most frequent lesion in the brain CT-scan (67.5%). After randomization, 96 patients were in the TXA group (53%). Demographic data, clinical, biological and radiological features were statistically comparable in the two groups of patients (‘TXA’ and ‘noTXA’). The needs of transfusion or neurosurgery, the mortality rate, the in-hospital length of stay and the dependency at 28-post-traumatic day were similar in the two groups of patients. However, pulmonary embolism was statistically more frequent in ‘TXA’ group (11.5 versus 2.4%, p = 0.02).
TXA is an interesting treatment in haemorrhagic shock. Its efficiency in head trauma is still debated and controversial. Its impact on the mortality and the needs of transfusion or surgery were not demonstrated in this study. Nevertheless, its safety worth to be studied in larger samples as we found a higher rate of pulmonary embolism in the treated group.
KeywordsTranexamic acid Traumatic brain injury Management Prognosis Emergency department Pulmonary embolism
Study concept and design (OCW, KCH); acquisition of the data (AS, AT, JM, AN, HK, BS); analysis of the data (OCW); drafting of the manuscript (OCW, AS, AN); critical revision of the manuscript (OCW, MB, NR); approval of final manuscript (OCW, NR).
Compliance with ethical standards
Conflict of interest
Olfa Chakroun-Walha, Amal Samet, Mouna Jerbi, Abdennour Nasri, Aziza Talbi, Hassen Kanoun, Basma Souissi, Kamilia Chtara, Mounir Bouaziz, Hichem Ksibi and Noureddine Rekik declare that they have no competing interest.
- 3.Jackisch J, Sethi D, Mitis F, et al. European facts and the Global status report on road safety. 2015; (WHO 2015). http://www.euro.who.int/__data/assets/pdf_file/0006/293082/European-facts-Global-Status-Report-road-safety-en.pdf. Accessed 15 June 2018.
- 6.CRASH-2 trial collaborators, Shakur H, Roberts I, Bautista R, et al. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet 2010; 376 (9734): 23–32. https://doi.org/10.1016/S0140-6736(10)60835-5.CrossRefGoogle Scholar
- 7.Roberts I. Shakur H, Coats T, et al. The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technol Assess. 2013;17(10):1–79. https://doi.org/10.3310/hta17100.CrossRefPubMedPubMedCentralGoogle Scholar
- 8.CRASH-2 trial collaborators, Roberts I, Shakur H, Afolabi A, et al. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet 2011;377(9771):1096–101. https://doi.org/10.1016/S0140-6736(11)60278-X (1101 e1091-2) CrossRefGoogle Scholar
- 10.Mahmood A, Roberts I, Shakur H. A nested mechanistic sub-study into the effect of tranexamic acid versus placebo on intracranial haemorrhage and cerebral ischaemia in isolated traumatic brain injury: study protocol for a randomised controlled trial (CRASH-3 Trial Intracranial Bleeding Mechanistic Sub-Study [CRASH-3 IBMS]). Trials. 2017;18:330. https://doi.org/10.1186/s13063-017-2073-6.CrossRefPubMedPubMedCentralGoogle Scholar
- 13.Dewan Y, Komolafe EO, Mejia-Mantilla JH, et al. CRASH-3-tranexamic acid for the treatment of significant traumatic brain injury: study protocol for an international randomized, double-blind, placebo-controlled trial. Trials. 2012;13:87. https://doi.org/10.1186/1745-6215-13-87.CrossRefPubMedPubMedCentralGoogle Scholar
- 16.Perel P, Al-Shahi Salman R, Kawahara T, Morris Z, Prieto-Merino D, Roberts I, et al. CRASH-2 (Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage) intracranial bleeding study: the effect of tranexamic acid in traumatic brain injury a nested randomised, placebo-controlled trial. Health Technol Assess. 2012;16(13):iii–xii. https://doi.org/10.3310/hta16130 (1–54).CrossRefPubMedGoogle Scholar
- 17.Gayet-Ageron A, Prieto-Merino D, Ker K,et al. Effect of treatment delay on the effectiveness and safety of antifibrinolytics in acute severe haemorrhage: a meta-analysis of individual patient-level data from 40138 bleeding patients. Lancet. 2018;391(10116):125–32. https://doi.org/10.1016/S0140-6736(17)32455-8.CrossRefPubMedPubMedCentralGoogle Scholar