• Ayman El-Menyar, Khalid Ahmed, Suhail Hakim, Ahad Kanbar, Saji Mathradikkal, Tariq Siddiqui, Hisham Jogol, Basil Younis, Ibrahim Taha, Ismail Mahmood, Ahmed Ajaj, Sajid Atique, Abubaker Alaieb, Ahmed Abdel-Aziz Bahey, Mohammad Asim, Guillaume Alinier, Nicholas R Castle, Ahammed Mekkodathil, Sandro Rizoli, and Hassan Al-Thani.
• Trauma & Vascular Surgery, Clinical Research, Hamad General Hospital, Hamad Medical Corporation (HMC), P.O Box 3050, Doha, Qatar. aymanco65@yahoo.com.
• Eur J Trauma Emerg Surg. 2022 Aug 1; 48 (4): 3089-3099.

BackgroundPrehospital administration of tranexamic acid (TXA) to injured patients is increasing worldwide. However, optimal TXA dose and need of a second infusion on hospital arrival remain undetermined. We investigated the efficacy and safety of the second in-hospital dose of TXA in injured patients receiving 1 g of TXA in the prehospital setting. We hypothesized that a second in-hospital dose of TXA improves survival of trauma patients.MethodsA prospective, double-blind, placebo-controlled randomized, clinical trial included adult trauma patients receiving 1 g of TXA in the prehospital settings. Patients were then blindly randomized to Group I (second 1-g TXA) and Group II (placebo) on hospital arrival. The primary outcome was 24-h (early) and 28-day (late) mortality. Secondary outcomes were thromboembolic events, blood transfusions, hospital length of stay (HLOS) and organs failure (MOF).ResultsA total of 220 patients were enrolled, 110 in each group. The TXA and placebo groups had a similar early [OR 1.000 (0.062-16.192); p = 0.47] and late mortality [OR 0.476 (95% CI 0.157-1.442), p = 0.18].The cause of death (n = 15) was traumatic brain injury (TBI) in 12 patients and MOF in 3 patients. The need for blood transfusions in the first 24 h, number of transfused blood units, HLOS, thromboembolic events and multiorgan failure were comparable in the TXA and placebo groups. In seriously injured patients (injury severity score > 24), the MTP activation was higher in the placebo group (31.3% vs 11.10%, p = 0.13), whereas pulmonary embolism (6.9% vs 2.9%, p = 0.44) and late mortality (27.6% vs 14.3%, p = 0.17) were higher in the TXA group but did not reach statistical significance.ConclusionThe second TXA dose did not change the mortality rate, need for blood transfusion, thromboembolic complications, organ failure and HLOS compared to a single prehospital dose and thus its routine administration should be revisited in larger and multicenter studies.Trial RegistrationClinicalTrials.gov Identifier: NCT03846973.© 2021. The Author(s).

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