Thrombolysis Outcome in Ischemic Stroke

NCT ID: NCT04309357

Last Updated: 2020-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 214 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2020-05-30

Brief Summary

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.

Detailed Description

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.

Conditions

Stroke, Acute; Thrombolytic Therapy; Alteplase; Mortality

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Alteplase

Alteplase in dose 0.9 mg/kg in acute ischemic patient with indications of thrombolytic therapy

Intervention Type: DRUG

Other Intervention Names

recombinant tissue plasminogen activator

Eligibility Criteria

Inclusion Criteria

1. writen inform consent

2. diagnosis of acute ischemic stroke by neurologist

3. met all criteria of thrombolytic therapy

4. resived full dose of alteplase

Exclusion Criteria

1. any contraindication of thrombolytic therapy

2. resived lower than 0.9 mg/kg alteplase

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mazandaran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Athena Sharifi Razavi

Assistant Professor in neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharifi-Razavi

Role: PRINCIPAL_INVESTIGATOR

Mazandaran University of Medical Science

Locations

Bu Ali Sina hospital , Mazandarn University of Medical Science

Sari, , Iran

Countries

Iran

Other Identifiers

2464

Identifier Type: -

Identifier Source: org_study_id