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

NCT ID: NCT03359434

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

455 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-05

Study Completion Date

2024-12-04

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

Conditions

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Acute Stroke Blood Pressure Cerebral Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Two measuring methods of blood pressure

Clearsight device (Edwards) around the finger

Intervention Type DEVICE

Continuous measurement of blood pressure with the Clearsight device (Edwards) around the finger, within 24 hours after reperfusion:

Intermittent blood pressure measurements with cuff.

Intervention Type DEVICE

Standard method: 35 blood pressure measurements with cuff within 24 hours after reperfusion

Interventions

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Clearsight device (Edwards) around the finger

Continuous measurement of blood pressure with the Clearsight device (Edwards) around the finger, within 24 hours after reperfusion:

Intervention Type DEVICE

Intermittent blood pressure measurements with cuff.

Standard method: 35 blood pressure measurements with cuff within 24 hours after reperfusion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient aged 18 years or older
* Treated for occlusion of the internal carotid arteries and/or proximal middle cerebral arteries (M1 and M2 segments), vertebral artery, and/or basilar artery
* Affiliated with or beneficiary of a Social Security plan
* Having received informed information about the study and having given consent to participate in the study

Exclusion Criteria

* Per-procedure hemorrhagic complications (before reperfusion is achieved)
* Patient benefiting from legal protection measures
* Pregnant or breastfeeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MAZIGHI Mikael, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique A. de Rothschild

Locations

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Fondation Ophtalmologique A de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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MMI_2017_12

Identifier Type: -

Identifier Source: org_study_id

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