Blood Pressure Measurement Methods and Prediction of Intracranial Hemorrhage After Thrombectomy in Stroke

Study Overview
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Brief Summary
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A monocentric, non-randomized, prospective study in which each patient is his/her own control. The study investigates 2 methods of blood pressure measurement, within the first 24 hours after reperfusion, i) Continuous measurement of blood pressure with the Clearsight device (Edwards) and ii) intermittent blood pressure measurements with cuff.

Detailed Description
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Patients will be followed for 72 hours: inclusion after reperfusion: clinical evaluation with NIHSS (National Institute of Health Stroke Score) score, measurement of blood pressure. within 24 hours after reperfusion: blood pressure measurements at 24 hours: NIHSS score. Between 24 and 36 hours :cerebral scan (assessment of hemorrhagic transformations and cerebral infarction volumes). 72 hours after reperfusion: brain scanner in case of hyperdensity on the initial scanner

Official Title
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Impact of Blood Pressure Measurement Methods for the Prediction of Intracranial Hemorrhage After Thrombectomy in Acute Stroke

Conditions
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Cerebral Hemorrhage, Acute Stroke, Blood Pressure

Intervention / Treatment
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* Device: Clearsight device (Edwards) around the finger
* Device: Intermittent blood pressure measurements with cuff.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Occlusion of internal carotid arteries or proximal middle cerebral arteries (segment M1). Reperfusion after a thrombectomy procedure (defined by a 2b-3 Thrombolysis In Cerebral Infarction (TICI) score). Exclusion Criteria: Per-procedure hemorrhagic complications (prior to reperfusion) Known pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Two measuring methods of blood pressure<br> | Device: Clearsight device (Edwards) around the finger<br>* Continuous measurement of blood pressure with the Clearsight device (Edwards) around the finger, within 24 hours after reperfusion:<br>Device: Intermittent blood pressure measurements with cuff.<br>* Standard method: 35 blood pressure measurements with cuff within 24 hours after reperfusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of intracranial hemorrhagic complications | number of intracranial hemorrhagic complications (symptomatic or asymptomatic) on brain scanner, evaluated with a double centralized blind reading | 36 hours after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Stroke, Blood Pressure, Cerebral Hemorrhage