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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03359434
Acronym
BP-METROLOGY
Enrollment
455
Registered
2017-12-02
Start date
2018-12-05
Completion date
2024-12-04
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke, Blood Pressure, Cerebral Hemorrhage

Keywords

Acute Stroke, Blood Pressure, Cerebral Hemorrhage

Brief summary

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

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

Interventions

DEVICEClearsight device (Edwards) around the finger

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

DEVICEIntermittent blood pressure measurements with cuff.

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

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurence of intracranial hemorrhagic complications36 hours after baselinenumber of intracranial hemorrhagic complications (symptomatic or asymptomatic) on brain scanner, evaluated with a double centralized blind reading

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMAZIGHI Mikael, MD PhD

Fondation Ophtalmologique A. de Rothschild

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026