Hemodynamic in Postreperfusion Period and Functional Recovery in Acute Ischemic Stroke Patients

Study Overview
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Brief Summary
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The investigators are suggtesting that lower goals of systolic blood pressure after intravenous thrombolysis may reduce the risk of hemorrhagic complications and improve functional outcomes after acute ischemic stroke.

Official Title
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The Influence of Different Hemodynamic Parameters in First 24 Hours After Intravenous Thrombolysis on Acute Ischemic Stroke Outcomes: A Randomised Clinical Trial

Conditions
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Acute Ischemic Stroke, Intracranial Hemorrhage

Intervention / Treatment
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* Other: Hemodynamic goal including lower goal of systolic blood pressure


Participation Criteria
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Eligibility Criteria
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Inclusion сriteria: ischemic stroke diagnosis performed intravenous thrombolysis (including wake up stroke) systolic blood pressure >140 mmHg informed consent or council of physician agreement Exclusion criteria: absence of informed consent or council of physician agreement pregnancy patients participainting in other clinical trial in the last 90 days any absolute contraindications to intravenous thrombolysis Сompletion criteria: failure to achieve hemodynamic goal for 20 minutes before the start of intravenous thrombolysis failure to achieve hemodynamic goal for 60 minutes in first 24 hours after intravenous thrombolysis relative arterial hypotension (SBP <100 mmHg for 60 minutes in first 24 hours after intravenous thrombolysis) unfavorable effect development (e.g. seizures, angioedema) informed consent is retracted

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group. Standart care<br>Standart hemodynamic goals: systolic blood pressure 160-185 mmHg in first 24 hours after intravenous thrombolysis | |
| Experimental: Systolic blood pressure ≤ 160 mmHg<br>Lower hemodynamic goals: systolic blood pressure ≤ 160 mmHg in first 24 hours after intravenous thrombolysis | Other: Hemodynamic goal including lower goal of systolic blood pressure<br>* Different hemodynamic goals in different study arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale score | Fucntional outcome (Modified Rankin Scale) will be assesed by telephone interview. Score from 0 to 6. Higher scores mean a worse outcome. | 90 day after intravenous thrombolysis | 
| Mortality rate |  | At 90 day after intravenous thrombolysis | 
| Rate of symptomatic intracranial hemorrhage | Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH | 24 hours after intravenous thrombolysis | 
| Rate of symptomatic intracranial hemorrhage | Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH | 7 days after intravenous thrombolysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in National Institutes of Health Stroke Scale (NIHSS) | Score form 0 to 42. Higher score indicates worse outcome | at 28 day after intravenous thrombolysis | 
| Rate of all Intracranial hemorrhage | Intracranial hemorrhage will be classified according to Heidelberg bleeding classification | 24 hours after intravenous thrombolysis | 
| Rate of all Intracranial hemorrhage | Intracranial hemorrhage will be classified according to Heidelberg bleeding classification | 7 days after intravenous thrombolysis | 
| Lengths of stay in ICU |  | at 90 day after intravenous thrombolysis | 
| Lengths of stay in hospital |  | at 90 day after intravenous thrombolysis | 
| Rate of acute kidney injury | Acute kidney injury will be assesed according to RIFLE Classification | 28 day after intravenous thrombolysis or at discharge |