The Effect of Tranexamic Acid on Neurosurgical Intervention in Spontaneous Intracerebral Hematoma: Data From 121 Surgically Treated Participants From the Tranexamic Acid in IntraCerebral Hemorrhage-2 Randomized Controlled Trial

Author:

Hollingworth Milo12ORCID,Woodhouse Lisa J.2ORCID,Law Zhe K.23ORCID,Ali Azlinawati24ORCID,Krishnan Kailash25ORCID,Dineen Robert A.67ORCID,Christensen Hanne8ORCID,England Timothy J.29,Roffe Christine10ORCID,Werring David11ORCID,Peters Nils12,Ciccone Alfonso13ORCID,Robinson Thompson14ORCID,Członkowska Anna15,Bereczki Dániel16,Egea-Guerrero Juan José17,Ozturk Serefnur18ORCID,Bath Philip M.25,Sprigg Nikola25ORCID

Affiliation:

1. Department of Neurosurgery, Nottingham University Hospitals, Nottingham, UK;

2. Stroke Trials Unit, Mental Health & Clinical Neurosciences, Queen's Medical Centre, School of Medicine, University of Nottingham, Nottingham, UK;

3. Department of Medicine, Faculty of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia;

4. Faculty of Health Sciences, School of Medical Imaging, University of Sultan Zainal Abidin, Kuala Nerus, Malaysia;

5. Stroke, Department of Acute Medicine, Nottingham University Hospitals, Nottingham, UK;

6. Radiological Sciences, Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, UK;

7. NIHR Nottingham Biomedical Research Centre, Nottingham, UK;

8. Department of Neurology, Copenhagen University Hospital, Bispebjerg, Denmark;

9. Stroke, Royal Derby Hospital, University Hospitals of Derby and Burton, Derby, UK;

10. Stroke Research, School of Medicine, Keele University, Newcastle under Lyme, UK;

11. Stroke Research Centre, Brain Repair & Rehabilitation, UCL Queen Square Institute of Neurology, London, UK;

12. Stroke Center and Department of Neurology, University Hospital Basel, University of Basel, Basel, Switzerland;

13. Azienda Socio Sanitaria Territoriale di Mantova, Mantova, Italy;

14. College of Life Sciences, University of Leicester, Leicester, UK;

15. Institute of Psychiatry and Neurology, Warsaw, Poland;

16. Department of Neurology, Semmelweis University, Budapest, Hungary;

17. Unidad de NeuroCríticos Hospital Univ. Virgen del Rocío, Sevilla, Spain;

18. Department of Neurology, Neurointensive Care- Stroke Center, Selcuk University Faculty of Medicine, Konya, Turkey

Abstract

BACKGROUND AND OBJECTIVES: An important proportion of patients with spontaneous intracerebral hemorrhage (ICH) undergo neurosurgical intervention to reduce mass effect from large hematomas and control the complications of bleeding, including hematoma expansion and hydrocephalus. The Tranexamic acid (TXA) for hyperacute primary IntraCerebral Hemorrhage (TICH-2) trial demonstrated that tranexamic acid (TXA) reduces the risk of hematoma expansion. We hypothesized that TXA would reduce the frequency of surgery (primary outcome) and improve functional outcome at 90 days in surgically treated patients in the TICH-2 data set. METHODS: Participants enrolled in TICH-2 were randomized to placebo or TXA. Participants randomized to either TXA or placebo were analyzed for whether they received neurosurgery within 7 days and their characteristics, outcomes, hematoma volumes (HVs) were compared. Characteristics and outcomes of participants who received surgery were also compared with those who did not. RESULTS: Neurosurgery was performed in 5.2% of participants (121/2325), including craniotomy (57%), hematoma drainage (33%), and external ventricular drainage (21%). The number of patients receiving surgery who received TXA vs placebo were similar at 4.9% (57/1153) and 5.5% (64/1163), respectively (odds ratio [OR] 0.893; 95% CI 0.619-1.289; P-value = .545). TXA did not improve outcome compared with placebo in either surgically treated participants (OR 0.79; 95% CI 0.30-2.09; P = .64) or those undergoing hematoma evacuation by drainage or craniotomy (OR 1.19 95% 0.51-2.78; P-value = .69). Postoperative HV was not reduced by TXA (mean difference −8.97 95% CI −23.77, 5.82; P-value = .45). CONCLUSION: TXA was not associated with less neurosurgical intervention, reduced HV, or improved outcomes after surgery.

Funder

Health Technology Assessment Programme

Publisher

Ovid Technologies (Wolters Kluwer Health)

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