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OpenTrials
Completed

NCT Number: NCT05517109

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhage Intracranial Hemorrhages Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City Hospital # 1 n.a. E.E. Volosevich

Arkhangelsk, 163000, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemodynamic goal including lower goal of systolic blood pressure

Other

Different hemodynamic goals in different study arms

Primary outcomes

  1. Modified Rankin Scale score

    Time frame: 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.

  2. Mortality rate

    Time frame: At 90 day after intravenous thrombolysis

  3. Rate of symptomatic intracranial hemorrhage

    Time frame: 24 hours after intravenous thrombolysis

    Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH

  4. Rate of symptomatic intracranial hemorrhage

    Time frame: 7 days after intravenous thrombolysis

    Symptomatic intracranial hemorrhage (sICH) according to SITS-MOST study description of sICH

Secondary outcomes

  1. Change in National Institutes of Health Stroke Scale (NIHSS)

    Time frame: at 28 day after intravenous thrombolysis

    Score form 0 to 42. Higher score indicates worse outcome

  2. Rate of all Intracranial hemorrhage

    Time frame: 24 hours after intravenous thrombolysis

    Intracranial hemorrhage will be classified according to Heidelberg bleeding classification

  3. Rate of all Intracranial hemorrhage

    Time frame: 7 days after intravenous thrombolysis

    Intracranial hemorrhage will be classified according to Heidelberg bleeding classification

  4. Lengths of stay in ICU

    Time frame: at 90 day after intravenous thrombolysis

  5. Lengths of stay in hospital

    Time frame: at 90 day after intravenous thrombolysis

  6. Rate of acute kidney injury

    Time frame: 28 day after intravenous thrombolysis or at discharge

    Acute kidney injury will be assesed according to RIFLE Classification

Sponsors and collaborators

Lead sponsor

Northern State Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2022
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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