Abraham Siju V, Thaha Fazil, Krishnan S Vimal, Shajan Athulya, Balakrishnan Jayaraj Mymbilly, Palatty Babu Urumese
Department of Emergency Medicine, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India.
Department of Neurology, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India.
Ann Indian Acad Neurol. 2017 Jan-Mar;20(1):36-40. doi: 10.4103/0972-2327.199911.
The guideline recommended dose of intravenous (i.v) recombinant tissue-type plasminogen activator (rt-PA) for acute ischemic stroke is 0.9 mg/kg in the European and American populations. In Asiatic population, some studies have shown that a lower dose of i.v rt-PA is equally efficacious.
To assess if there is a need for a dose optimization for i.v rt-PA study among Indians.
A prospective, observational database of acute stroke cases that presented to a tertiary care institute over a period of 1 year was made.
The data procured using a prestructured elaborate pro forma. Based on the dose of rt-PA received, the individuals were divided into three groups; Group 1 (0.6-0.7 mg/kg), Group 2 (0.7-0.8 mg/kg), and Group 3 (0.8-0.9 mg/kg). Improvement was assessed in each group and between the thrombolysed and nonthrombolysed individuals.
The nonparametric Mann-Whitney U-test (Wilcoxon rank-sum test) was applied for assessing improvement of National Institutes of Health Stroke Scale score with significance level of α < 0.05 ( < 0.012) and compliance level at 95%.
Between the thrombolysed ( = 46) and nonthrombolysed ( = 113) group, there was a statistically significant neurological improvement in the thrombolysed group. Clinical improvement was noted in 75%, 85.7%, and 66.7% of individuals receiving rt-PA in Groups 1, 2, and 3, respectively. Four out of the five who developed a clinically significant intracranial hemorrhage were thrombolysed at a dose of 0.8-0.9 mg/kg rt-PA (Group 3).
There is a need for a properly randomized, dose optimization study of i.v rt-PA in the Indian subcontinent.
