Tranexamic acid for spontaneous intracerebral hemorrhage: a randomized controlled study
10.3760/cma.j.issn.1673-4165.2020.04.005
- VernacularTitle:氨甲环酸治疗自发性脑出血:随机对照研究
- Author:
Jie NI
1
;
Luna WANG
;
Fang WANG
;
Min JIANG
;
Dujuan SHA
Author Information
1. 南京鼓楼医院急诊科 210008
- From:
International Journal of Cerebrovascular Diseases
2020;28(4):266-270
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the safety and effectiveness of tranexamic acid in the treatment of spontaneous intracerebral hemorrhage.Methods:Patients with spontaneous intracerebral hemorrhage admitted to the Departments of Emergency and Neurology, Nanjing Drum Tower Hospital from December 2015 to December 2018 were enrolled prospectively. The patients were randomly divided into two groups according to a random number table: tranexamic acid group and control group. All patients received conventional treatment. On this basis, 1 g of tranexamic acid injection was given to the tranexamic acid group, dissolved in 100 ml of normal saline, intravenous injection for 10 min; then 1 g of tranexamic acid was given, dissolved in 250 ml of normal saline, intravenous drip for 8 h. The control group was given an equal volume of normal saline. The main outcome measures were good outcome (defined as modified Rankin Scale score0-2) and mortality at 90 d after treatment. The secondary outcome was hematoma enlargement at 24 h after treatment and the National Institutes of Health Stroke Scale (NIHSS) score at 7 and 30 days after treatment. Platelet count and fibrinogen level were measured before treatment and 4 h after the infusion of tranexamic acid. Various adverse events were monitored.Results:A total of 150 patients were included, including 83 males (55.3%). There were 73 patients in the tranexamic acid group and 77 in the control group. There was no statistically significant difference in baseline data between the two groups. The rate of good outcome in the tranexamic acid group at 90 d was significantly higher than that in the control group (57.5% vs. 40.3%; χ2=4.476, P=0.034), while there were no significant differences in mortality rate (0% vs. 1.3%; Fisher's exact test P=1.000) and the proportion of patients with hematoma enlargement at 24 h (6.8% vs. 15.6%; χ2=2.845, P=0.092). The NIHSS score at 7 d (9.26±3.35 vs. 11.68±4.25; t=3.859, P<0.001) and at 30 d (5.45±2.52 vs. 7.38±3.28; t=4.030, P<0.001) in the tranexamic acid group were significantly lower than those of the control group. Fibrinogen in the tranexamic acid group increased significantly after treatment compared with baseline (4.20±0.56 g/L vs. 3.33±0.60 g/L; t=8.997, P<0.001), and was significantly higher than that in the control group after treatment (4.20±0.56 g/L vs. 3.30±0.55 g/L; t=9.906, P<0.001). No adverse events such as venous thromboembolism, ischemic events, and seizures were observed. Conclusion:Tranexamic acid can promote the recovery of neurological function, and improve the outcome of patients with acute spontaneous intracerebral hemorrhage, and the safety is good.