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

Not Applicable

Completed

• Conditions: Intracranial Hemorrhage; Acute Ischemic Stroke
• Interventions: Other: Hemodynamic goal including lower goal of systolic blood pressure

• Registration Number: NCT05517109
• Lead Sponsor: Northern State Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-12
• Study First Submitted: 2022-08-06
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-26
• Primary Completion: 2024-04-30
• Study Completion: 2024-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systolic blood pressure ≤ 160 mmHg	Hemodynamic goal including lower goal of systolic blood pressure	Lower hemodynamic goals: systolic blood pressure ≤ 160 mmHg in first 24 hours after intravenous thrombolysis

Primary Outcome Measures

Name	Time	Method
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	7 days after intravenous thrombolysis	Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH

Secondary Outcome Measures

Name	Time	Method
Rate of acute kidney injury	28 day after intravenous thrombolysis or at discharge	Acute kidney injury will be assesed according to RIFLE Classification
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	7 days after intravenous thrombolysis	Intracranial hemorrhage will be classified according to Heidelberg bleeding classification
Lengths of stay in ICU	at 90 day after intravenous thrombolysis
Lengths of stay in hospital	at 90 day after intravenous thrombolysis

Trial Locations

Locations (1)

City Hospital # 1 n.a. E.E. Volosevich; 🇷🇺 Arkhangelsk, Russian Federation