Stroke, Acute Clinical Trial
Official title:
Evaluation of Thrombolytic Therapy in Acute Ischemic Stroke Outcome: A Cohort Study From North of Iran
Consecutive patients with diagnosis of acute ischemic stroke and candidate of thrombolytic
therapy during Jan 2017-Mar 2019 in BuAli Sina Hospital ,Sari, Iran, enrolled to this cohort
study.
The demographic data, stroke characteristis, lab data and ... recorded. Then patients
evaluate every 3 month until 12 month for fallow up.
The variables of the study, including demographic characteristics, risk factors, complete
drug history, nosocomial infection and other in-hospital events, hemorrhagic complications,
duration of hospitalization,door to needle time, symptom to needle time, clinical and imaging
characteristics of resent stroke, laboratory data including fasting blood glucose, lipid
profile (total cholesterol, triglyceride, LDL, HDL), hematology markers (CBC diff, HGB,
platelet), coagulation markers (PT, PTT, INR), liver function test (ALT, AST, ALP, Bill) and
renal function test (BUN, Cr, Cr cl) were collected. All patients underwent a brain computed
tomography scan early on the admission and after 24 hours. Cardiological evaluation including
Electrocardiogram and echocardiography performed for all patients. Carotid and
vertebrobasillar assessed by Doppler ultrasound or magnetic resonance angiography (MRA).
Stroke severity estimated by using modified Rankin Scale (mRS) and National Institutes of
Health Stroke Scale(NIHSS) scores on the first day of admission and at discharge by a
neurology resident. Then patient evaluate every 3 months until 12 m for fallow up and in each
visit vital sign, patient clinical status, any event, Barthel index was recorded.
Safety endpoints of this study were any adverse events clinically relevant to alteplase,
specially hemorrhagic complications.
All patients who met all inclusion and exclusion criteria treated with 0.9 mg/kg recombinant
tissue plasminogen activator (Actilyse, Boehringer Industry, Germany) up to maximum of 90 mg,
10% of which was injected as a blous dose and remainder infused over an hour.
Primary outcome of this study was alteplase effect in reduce morbidity rate defined by NIHSS
and mRS score reduction and rate of functional independence at 3,6 and 12 months Barthel
index in fallow up. Minimal clinically important difference defined as reduce NIHSS score at
least 25% or MRS score 2 point at discharge day in comparison to admission day. In fallow up
evaluations Barthel index 85-100 was considered favorable outcome. Binary outcomes included
independence compared with disability or death.
Secondary outcome was rtPA therapy safety that assessed by fatal intra cranial hemorrhage.
Also, mortality rate, intracranial hemorrhage rate, any hemorrhagic event rate and any
adverse event rate assessed.
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