One Versus Two Doses of Tranexamic Acid in Surgically Treated Extracapsular Hip Fractures

Summary

The goal of this clinical trial is to learn whether giving one dose or two doses of tranexamic acid can safely lower blood loss in older adults having surgery for certain hip fractures. The study includes adults aged 65 years or older who need surgery for pertrochanteric or subtrochanteric hip fractures. The main questions the study aims to answer are: * Does giving two doses of tranexamic acid lower the need for blood transfusions compared to one dose? * Does tranexamic acid help keep hemoglobin levels higher after surgery? * Is tranexamic acid safe in this group of participants? Researchers will compare participants who receive one dose of tranexamic acid with those who receive two doses to see which approach works better and is safe. Participants will: * Receive either one dose of tranexamic acid before surgery or two doses, one before and one after surgery * Have standard surgery to fix their hip fracture within 48 hours of hospital admission * Be monitored during their hospital stay for blood loss, transfusions, and medical problems * Be followed for up to 90 days after surgery to check for safety A total of 120 participants will take part in this study, which is being conducted at the University Clinic "St. Naum Ohridski" in Skopje, North Macedonia.

Timeline

Start

2026-02-17

Primary completion

2027-05

Completion

2027-09

Publications

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• Results CRASH-3 trial collaborators. Effects of tranexamic acid on death, disability, vascular occlusive events and other morbidities in patients with acute traumatic brain injury (CRASH-3): a randomised, placebo-controlled trial. Lancet. 2019 Nov 9;394(10210):1713-1723. doi: 10.1016/S0140-6736(19)32233-0. Epub 2019 Oct 14.
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• Results Sing CW, Lin TC, Bartholomew S, Bell JS, Bennett C, Beyene K, Bosco-Levy P, Bradbury BD, Chan AHY, Chandran M, Cooper C, de Ridder M, Doyon CY, Droz-Perroteau C, Ganesan G, Hartikainen S, Ilomaki J, Jeong HE, Kiel DP, Kubota K, Lai EC, Lange JL, Lewiecki EM, Lin J, Liu J, Maskell J, de Abreu MM, O'Kelly J, Ooba N, Pedersen AB, Prats-Uribe A, Prieto-Alhambra D, Qin SX, Shin JY, Sorensen HT, Tan KB, Thomas T, Tolppanen AM, Verhamme KMC, Wang GH, Watcharathanakij S, Wood SJ, Cheung CL, Wong ICK. Global Epidemiology of Hip Fractures: Secular Trends in Incidence Rate, Post-Fracture Treatment, and All-Cause Mortality. J Bone Miner Res. 2023 Aug;38(8):1064-1075. doi: 10.1002/jbmr.4821. Epub 2023 May 29.

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