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OpenTrials
Completed

NCT Number: NCT03359434

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

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.

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Key information

Conditions

Acute Stroke Blood Pressure Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages 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

Observational

Primary location

Fondation Ophtalmologique A de Rothschild

Paris, 75019, France

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Clearsight device (Edwards) around the finger

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.

Device

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

Primary outcomes

  1. Occurence of intracranial hemorrhagic complications

    Time frame: 36 hours after baseline

    number of intracranial hemorrhagic complications (symptomatic or asymptomatic) on brain scanner, evaluated with a double centralized blind reading

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: BP-METROLOGY

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Dec 2, 2017
Registry last updated
Apr 9, 2026

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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