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

NCT03359434 | Completed

• 1 other identifier: MMI_2017_12
• Study Type: observational
• Target: 455
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke; Blood Pressure; Cerebral Hemorrhage

Keywords

Acute Stroke; Blood Pressure; Cerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Two measuring methods of blood pressure

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

Interventions

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:

Two measuring methods of blood pressure

Intermittent blood pressure measurements with cuff. DEVICE

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

Two measuring methods of blood pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with thrombectomy after acute stroke

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A de Rothschild

Paris, 75019, France

Location

Related Publications (1)

• Matthys A, Bedoucha L, Di Meglio F, Sabben C, Obadia M, Le Cossec C, Labreuche J, Boursin P, Mazighi M, Di Meglio L. BP-METROLOGY: non-invasive continuous blood pressure monitoring to predict haemorrhagic transformation after endovascular thrombectomy. Eur Stroke J. 2026 Mar 1;11(3):aakag012. doi: 10.1093/esj/aakag012.

  PMID: 41871383 RESULT

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MAZIGHI Mikael, MD PhD

  Fondation Ophtalmologique A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: December 5, 2018
• Primary Completion: December 17, 2023
• Study Completion: December 4, 2024
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

FR (1)