Generic placeholder image

Reviews on Recent Clinical Trials

Editor-in-Chief

ISSN (Print): 1574-8871
ISSN (Online): 1876-1038

Clinical Trial

Intravenous Tranexamic Acid for Subdural and Epidural Intracranial Hemorrhage: Randomized, Double‐Blind, Placebo-Controlled Trial

Author(s): Pouya Ebrahimi, Javad Mozafari*, Reza Bahrami Ilkhchi, Mohammad Ghasem Hanafi and Maryam Mousavinejad

Volume 14, Issue 4, 2019

Page: [286 - 291] Pages: 6

DOI: 10.2174/1574887114666190620112829

Price: $65

Abstract

Background: Recovery of patients with traumatic brain injury largely depends on the reduction in secondary brain damage. The present study aims at investigating the effect of Tranexamic Acid (TXA) administration within the first hours of brain trauma in the emergency department (ED).

Methods: This randomized, double-blind, placebo-controlled clinical trial was carried out in patients with subdural and epidural hemorrhage. Patients with any type of bleeding were assigned into two groups of TXA and 0.9% normal saline as placebo. The rate of intracranial hemorrhage after surgery was assessed by CT-scan and amount of hemoglobin (Hb) was measured immediately before surgery and after 6 hours of surgery.

Results: A total of 80 participants were randomly assigned into four groups of 20 people. There was a significant difference in the mean of intraoperative bleeding during surgery in patients receiving TXA and placebo in both SDH (Subdural hematoma) and EDH (Epidural Hemorrhage) groups (P= 0.012). The Hb drop amount had no significant difference with placebo (P< 0.0001). No complications were observed in any of the intervention and control groups during the study as well.

Conclusion: The use of TXA may reduce bleeding, however, based on the results of this study, such effect was not statistically significant in controlling the epidural and subdural hemorrhage, but clinical trials with a higher sample size are suggested for further investigation in this regard.

Keywords: Emergency medicine, intraparenchymal hemorrhage, tranexamic acid, trauma, clinical trial, hemoglobin (Hb).

Graphical Abstract
[1]
Katz-Leurer M, Zohar N, Boum A, Keren O. Monitoring changes in heart rate, as an indicator of the cardiovascular autonomic nervous function, among patients at the sub-acute phase post-brain damage during a physiotherapy session: A preliminary investigation. Brain Inj 2014; 28(1): 127-31.
[http://dx.doi.org/10.3109/02699052.2013.848381] [PMID: 24328738]
[2]
Khan F, Baguley IJ, Cameron ID. 4: Rehabilitation after traumatic brain injury. Med J Aust 2003; 178(6): 290-5.
[PMID: 12633489]
[3]
Faul M, Coronado V. Epidemiology of traumatic brain injury. Handb Clin Neurol 2015; 127: 3-13.
[http://dx.doi.org/10.1016/B978-0-444-52892-6.00001-5] [PMID: 25702206]
[4]
Zweckberger K, Hackenberg K, Jung CS, et al. Glibenclamide reduces secondary brain damage after experimental traumatic brain injury. Neuroscience 2014; 272: 199-206.
[http://dx.doi.org/10.1016/j.neuroscience.2014.04.040] [PMID: 24792709]
[5]
Terpolilli NA, Kim SW, Thal SC, Kuebler WM, Plesnila N. Inhaled nitric oxide reduces secondary brain damage after traumatic brain injury in mice. J Cereb Blood Flow Metab 2013; 33(2): 311-8.
[http://dx.doi.org/10.1038/jcbfm.2012.176] [PMID: 23188422]
[6]
Kim HI, Oh YJ, Cho YN, Choi YC. Subdural hemorrhage mimicking peripheral neuropathy. J Korean Neurosurg Soc 2014; 56(2): 166-7.
[http://dx.doi.org/10.3340/jkns.2014.56.2.166] [PMID: 25328658]
[7]
Bouget J, Oger E. Emergency admissions for major haemorrhage associated with direct oral anticoagulants. Thromb Res 2015; 136(6): 1190-4.
[http://dx.doi.org/10.1016/j.thromres.2015.10.036] [PMID: 26545315]
[8]
Huang YH, Lee TC, Lee TH, Yang KY, Liao CC. Remote epidural hemorrhage after unilateral decompressive hemicraniectomy in brain-injured patients. J Neurotrauma 2013; 30(2): 96-101.
[http://dx.doi.org/10.1089/neu.2012.2563] [PMID: 23013227]
[9]
Lobato RD, Alen JF, Perez-Nuñez A, et al. Value of serial CT scanning and intracranial pressure monitoring for detecting new intracranial mass effect in severe head injury patients showing lesions type I-II in the initial CT scan. Neurocirugia (Asturias, Spain) 2005; 16(3): 217-34.
[http://dx.doi.org/10.1016/S1130-1473(05)70405-X] [PMID: 16007322]
[10]
Tengborn L, Blombäck M, Berntorp E. Tranexamic acid--an old drug still going strong and making a revival. Thromb Res 2015; 135(2): 231-42.
[http://dx.doi.org/10.1016/j.thromres.2014.11.012] [PMID: 25559460]
[11]
Kamhieh Y, Fox H. Tranexamic acid in epistaxis: a systematic review. Clin Otolaryngol 2016; 41(6): 771-6.
[http://dx.doi.org/10.1111/coa.12645]
[12]
Binder LM. A review of mild head trauma. Part II: Clinical implications. J Clin Exp Neuropsychol 1997; 19(3): 432-57.
[http://dx.doi.org/10.1080/01688639708403871] [PMID: 9268817]
[13]
Waly NG. Local antifibrinolytic treatment with tranexamic acid in hemophilic children undergoing dental extractions. Egypt Dent J 1995; 41(1): 961-8.
[PMID: 9497628]
[14]
Abrishami A, Chung F, Wong J. Topical application of antifibrinolytic drugs for on-pump cardiac surgery: A systematic review and meta-analysis. Can J Anaesth 2009; 56(3): 202-12.
[http://dx.doi.org/10.1007/s12630-008-9038-x]
[15]
Miller JB, Schoenberg MR, Bilder RM. Consolidated Standards of Reporting Trials (CONSORT): Considerations for neuropsychological research. Clin Neuropsychol 2014; 28(4): 575-99.
[http://dx.doi.org/10.1080/13854046.2014.907445] [PMID: 24766549]
[16]
Zhang Z. Univariate description and bivariate statistical inference: the first step delving into data. Ann Transl Med 2016; 4(5): 91.
[http://dx.doi.org/10.21037/atm.2016.02.11] [PMID: 27047950]
[17]
Sarris I, Arafa A, Konaris L, Kadir RA. Topical use of tranexamic acid to control perioperative local bleeding in gynaecology patients with clotting disorders: two cases. Haemophilia 2007; 13(1): 115-6.
[http://dx.doi.org/10.1111/j.1365-2516.2006.01386.x]
[18]
Abul-Azm A, Abdullah KM. Effect of topical tranexamic acid in open heart surgery. Eur J Anaesthesiol 2006; 23(5): 380-4.
[http://dx.doi.org/10.1017/S0265021505001894] [PMID: 16438759]
[19]
Fawzy H, Elmistekawy E, Bonneau D, Latter D, Errett L. Can local application of Tranexamic acid reduce post-coronary bypass surgery blood loss? A randomized controlled trial. J Cardiothorac Surg 2009; 4: 25.
[http://dx.doi.org/10.1186/1749-8090-4-25] [PMID: 19538741]
[20]
Hanif M, Nourei SM, Dunning J. Does the use of topical tranexamic acid in cardiac surgery reduce the incidence of post-operative mediastinal bleeding? Interact Cardiovasc Thorac Surg 2004; 3(4): 603-5.
[http://dx.doi.org/10.1016/j.icvts.2004.07.005] [PMID: 17670322]
[21]
Yasim A, Asik R, Atahan E. Effects of topical applications of aprotinin and tranexamic acid on blood loss after open heart surgery. Anatol J Cardiol 2005; 5(1): 36-40.
[22]
CRASH-2 Collaborators, Intracranial Bleeding Study. Effect of tranexamic acid in traumatic brain injury: a nested randomised, placebo controlled trial (CRASH-2 Intracranial Bleeding Study). BMJ 2011; 343: d3795.
[http://dx.doi.org/10.1136/bmj.d3795] [PMID: 21724564]
[23]
Yutthakasemsunt S, Kittiwatanagul W, Piyavechvirat P, Thinkamrop B, Phuenpathom N, Lumbiganon P. Tranexamic acid for patients with traumatic brain injury: A randomized, double-blinded, placebo-controlled trial. BMC Emerg Med 2013; 13: 20.
[http://dx.doi.org/10.1186/1471-227X-13-20] [PMID: 24267513]
[24]
Zehtabchi S, Abdel Baki SG, Falzon L, Nishijima DK. Tranexamic acid for traumatic brain injury: A systematic review and meta-analysis. Am J Emerg Med 2014; 32(12): 1503-9.
[http://dx.doi.org/10.1016/j.ajem.2014.09.023] [PMID: 25447601]
[25]
Cap AP, Baer DG, Orman JA, Aden J, Ryan K, Blackbourne LH. Tranexamic acid for trauma patients: A critical review of the literature. J Trauma 2011; 71(1)(Suppl.): S9-S14.
[http://dx.doi.org/10.1097/TA.0b013e31822114af] [PMID: 21795884]
[26]
Majima N, Nishihara I, Yamaguchi K, Kawakami M. Usefulness of tranexamic acid in patients with severe head injury. Japan J Anesthesiol 2013; 62(4): 410-5.
[27]
Harvey V, Perrone J, Kim P. Does the use of tranexamic acid improve trauma mortality? Ann Emerg Med 2014; 63(4): 460-2.
[http://dx.doi.org/10.1016/j.annemergmed.2013.08.028] [PMID: 24095056]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy