TOSSI: Thrombolysis Outcome in Ischemic Stroke

• Sponsor: Mazandaran University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT04309357
• Collaborator: (none)
• Enrollment: 214
• Location: 1
• Actual Duration (Months): 40.9
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute; Thrombolytic Therapy; Alteplase; Mortality	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 Design

• Study Type: Observational
• Actual Enrollment: 214 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Thrombolytic Therapy in Acute Ischemic Stroke Outcome: A Cohort Study From North of Iran
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Apr 30, 2020
• Actual Study Completion Date: May 30, 2020

Outcome Measures

Primary Outcome Measures

1. Ischemic stroke outcome [3 months]

   evaluation of alteplase effect in morbidity of patient by using barthel index

Secondary Outcome Measures

1. ischemic stroke mortality [3 months]

   mortality of patients who received alteplase

2. frequency of adverse event [3 months]

   number of any adverse event of alteplase during study

3. frequency of fatal adverse event [3 months]

   number of fatal adverse event of alteplase during study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bu Ali Sina hospital , Mazandarn University of Medical Science	Sari		Iran, Islamic Republic of

Sponsors and Collaborators

• Mazandaran University of Medical Sciences

Investigators

• Principal Investigator: Sharifi-Razavi, Mazandaran University of Medical Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Athena Sharifi Razavi, Assistant Professor in neurology, Mazandaran University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT04309357
• Other Study ID Numbers: 2464
• First Posted: Mar 16, 2020
• Last Update Posted: Jul 9, 2020
• Last Verified: Jul 1, 2020

• 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
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Tissue Plasminogen Activator; Plasminogen

Study Results

No Results Posted as of Jul 9, 2020