Efficacy and safety of the second in-hospital dose of tranexamic acid after receiving the prehospital dose: double-blind randomized controlled clinical trial in a level 1 trauma center

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, Hassan Al-Thani

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

3 Downloads (Pure)

Abstract

Background: Prehospital 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. Methods: A 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). Results: A 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. Conclusion: The 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 registration: ClinicalTrials.gov Identifier: NCT03846973.

Original languageEnglish
Number of pages11
JournalEuropean Journal of Trauma and Emergency Surgery
Early online date15 Dec 2021
DOIs
Publication statusE-pub ahead of print - 15 Dec 2021
Externally publishedYes

Fingerprint

Dive into the research topics of 'Efficacy and safety of the second in-hospital dose of tranexamic acid after receiving the prehospital dose: double-blind randomized controlled clinical trial in a level 1 trauma center'. Together they form a unique fingerprint.

Cite this