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.

Abstract:

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.

journal_name

Ann Indian Acad Neurol

authors

Abraham SV,Thaha F,Krishnan SV,Shajan A,Balakrishnan JM,Palatty BU

doi

10.4103/0972-2327.199911

subject

Has Abstract

pub_date

2017-01-01 00:00:00

pages

36-40

issue

1

eissn

0972-2327

issn

1998-3549

pii

AIAN-20-36

journal_volume

20

pub_type

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