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Blood Pressure Measurement Methods and Prediction of Intracranial Hemorrhage After Thrombectomy in Stroke (BP-METROLOGY)

F

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Conditions

Cerebral Hemorrhage
Acute Stroke
Blood Pressure

Treatments

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

Study type

Observational

Funder types

NETWORK

Identifiers

NCT03359434
MMI_2017_12

Details and patient eligibility

About

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.

Full 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

Enrollment

455 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

455 participants in 1 patient group

Two measuring methods of blood pressure
Treatment:
Device: Clearsight device (Edwards) around the finger
Device: Intermittent blood pressure measurements with cuff.

Trial contacts and locations

1

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Central trial contact

Amélie Yavchitz, MD PhD

Data sourced from clinicaltrials.gov

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