Cerebral Hemodynamics During Early Verticalization After (Successful) Thrombectomy Poststroke

• Conditions: Stroke; Healthy
• Interventions: Procedure: Verticalization

• Registration Number: NCT04573114
• Lead Sponsor: University of Zurich

Brief Summary

This is a proof-of-concept study with a prospective observational design, where the association between progressive levels of verticalization and cerebral blood flow velocity (Ultrasound) in subacute stroke patients and healthy subjects will be investigated.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-02
• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-05
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-25
• Last Update Posted: 2021-11-29
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• First-ever ischemic stroke in the territory of the middle cerebral artery (MCA)
• ≤12 hours after mechanical thrombectomy
• Conscious
• Hemodynamically stable
• 18 years or older
• Informed consent of the patient and/ or legal representative

Exclusion Criteria

• Verticalization not allowed according to treating physician
• Known pre-stroke disease affecting cerebral blood flow
• Temporal bone windows insufficient to enable ultrasound penetration
• Intubation anticipated or occurred
• Venous thromboembolism
• Symptomatic intracranial hemorrhage

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy	Verticalization	-
Stroke subjects	Verticalization	-

Primary Outcome Measures

Name	Time	Method
Blood flow velocity	within 12 hours post thrombectomy	Cerebral blood flow velocity measured with transcranial doppler ultrasound

Secondary Outcome Measures

Name	Time	Method
Blood pressure	within 12 hours post thrombectomy	Systolic and Diastolic pressure
Neurological status	within 12 hours post thrombectomy	Glasgow Coma Scale - GCS (Maximum score 15 - higher scores mean a better outcome)
Heart rate	within 12 hours post thrombectomy	Number of contractions (beats) of the heart per minute
Oxygen saturation	within 12 hours post thrombectomy	Relative measure of the concentration of oxygen in the blood
Adverse events	within 12 hours post thrombectomy	headache, focal edema, seizures, hemorrhagic transformation
Impairment caused by a stroke	within 12 hours post thrombectomy	National Institutes of Health Stroke Scale - NIHSS (Maximum score 42 - higher scores mean a worse outcome)

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zürich, Zurich, Switzerland