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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke; Intracranial Hemorrhage
• Intervention / Treatment: Other: Hemodynamic goal including lower goal of systolic blood pressure

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangelsk, Russian Federation, 163000
    • City Hospital # 1 n.a. E.E. Volosevich

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group. Standart care; Standart hemodynamic goals: systolic blood pressure 160-185 mmHg in first 24 hours after intravenous thrombolysis
Experimental: Systolic blood pressure ≤ 160 mmHg; 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; Different hemodynamic goals in different study arms

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northern State Medical University
• Investigators: Study Director: Mikhail Kirov, PhD, Northen state medical university; Study Chair: Alexey Avidzba, Northen state medical university

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: August 6, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia; Hemorrhage; Intracranial Hemorrhages
• Other Study ID Numbers: IVT-160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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