Thrombolysis Outcome in Ischemic Stroke (TOSSI)

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.

Study Overview

• Status: Completed
• Conditions: Mortality; Stroke, Acute; Thrombolytic Therapy; Alteplase
• Intervention / Treatment: Drug: Alteplase

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.

• Study Type: Observational
• Enrollment (Actual): 214

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Sari, Iran, Islamic Republic of
    • Bu Ali Sina hospital , Mazandarn University of Medical Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All consecutive patient with diagnosis of acute ischemic stroke that met all criteria of thrombolytic therapy, that reffered to Bu Ali Sina hospital during jan 2017-mar 2019, enrolled to this study

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemic stroke outcome	evaluation of alteplase effect in morbidity of patient by using barthel index	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ischemic stroke mortality	mortality of patients who received alteplase	3 months
frequency of adverse event	number of any adverse event of alteplase during study	3 months
frequency of fatal adverse event	number of fatal adverse event of alteplase during study	3 months

Collaborators and Investigators

• Sponsor: Mazandaran University of Medical Sciences
• Investigators: Principal Investigator: Sharifi-Razavi, mazandaran university of medical science

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator; Plasminogen
• Other Study ID Numbers: 2464

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No