title: 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: BACKGROUND
  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.
  
  
  OBJECTIVE
  To assess if there is a need for a dose optimization for i.v rt-PA study among Indians.
  
  
  METHODS
  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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  There is a need for a properly randomized, dose optimization study of i.v rt-PA in the Indian subcontinent.
authors.affiliation: Department of Emergency Medicine, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India.
authors.forename: Siju V
authors.initials: SV
authors.lastname: Abraham
authors.affiliation: Department of Neurology, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India.
authors.forename: Fazil
authors.initials: F
authors.lastname: Thaha
authors.affiliation: Department of Emergency Medicine, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India.
authors.forename: S Vimal
authors.initials: SV
authors.lastname: Krishnan
authors.affiliation: Department of Emergency Medicine, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India.
authors.forename: Athulya
authors.initials: A
authors.lastname: Shajan
authors.affiliation: Department of Emergency Medicine, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India.
authors.forename: Jayaraj Mymbilly
authors.initials: JM
authors.lastname: Balakrishnan
authors.affiliation: Department of Emergency Medicine, Jubilee Mission Medical College and Research Institute, Thrissur, Kerala, India.
authors.forename: Babu Urumese
authors.initials: BU
authors.lastname: Palatty
keywords: Acute ischemic stroke; India; dose optimization; recombinant tissue-plasminogen activator; thrombolysis