Annals of Indian Academy of Neurology
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ORIGINAL ARTICLE
Year : 2017  |  Volume : 20  |  Issue : 1  |  Page : 36-40

The need for a population-based, dose optimization study for recombinant tissue plasminogen activator in acute ischemic stroke: A study from a tertiary care teaching hospital from South India


1 Department of Emergency Medicine, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India
2 Department of Neurology, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India

Correspondence Address:
Siju V Abraham
Department of Emergency Medicine, Jubilee Mission Medical College and Research Institute, Bishop Alapatt Road, Thrissur - 680 005, Kerala
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0972-2327.199911

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Context: 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. Aims: To assess if there is a need for a dose optimization for i.v rt-PA study among Indians. Setting and Design: A prospective, observational database of acute stroke cases that presented to a tertiary care institute over a period of 1 year was made. Methods: 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. Statistical Analysis Used: 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 (P < 0.012) and compliance level at 95%. Results: Between the thrombolysed (n = 46) and nonthrombolysed (n = 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). Conclusion: There is a need for a properly randomized, dose optimization study of i.v rt-PA in the Indian subcontinent.


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