Acute Ischemic Stroke, Intracranial Hemorrhage
Conditions
Brief summary
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.
Interventions
OTHERHemodynamic goal including lower goal of systolic blood pressure
Different hemodynamic goals in different study arms
Sponsors
Northern State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale score | 90 day after intravenous thrombolysis | Fucntional outcome (Modified Rankin Scale) will be assesed by telephone interview. Score from 0 to 6. Higher scores mean a worse outcome. |
| Mortality rate | At 90 day after intravenous thrombolysis | — |
| Rate of symptomatic intracranial hemorrhage | 24 hours after intravenous thrombolysis | Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lengths of stay in ICU | at 90 day after intravenous thrombolysis | — |
| Rate of acute kidney injury | 28 day after intravenous thrombolysis or at discharge | Acute kidney injury will be assesed according to RIFLE Classification |
| Lengths of stay in hospital | at 90 day after intravenous thrombolysis | — |
| Change in National Institutes of Health Stroke Scale (NIHSS) | at 28 day after intravenous thrombolysis | Score form 0 to 42. Higher score indicates worse outcome |
| Rate of all Intracranial hemorrhage | 24 hours after intravenous thrombolysis | Intracranial hemorrhage will be classified according to Heidelberg bleeding classification |
Countries
Russia
Outcome results
None listed