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

Primary Purpose

Acute Stroke, Blood Pressure, Cerebral Hemorrhage

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Clearsight device (Edwards) around the finger

Intermittent blood pressure measurements with cuff.

About this trial

This is an interventional prevention trial for Acute Stroke focused on measuring Acute Stroke, Blood Pressure, Cerebral Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Occlusion of internal carotid arteries or proximal middle cerebral arteries (segment M1).
Reperfusion after a thrombectomy procedure (defined by a 2b-3 Thrombolysis In Cerebral Infarction (TICI) score).

Exclusion Criteria:

Per-procedure hemorrhagic complications (prior to reperfusion)
Known pregnancy

Sites / Locations

Fondation Ophtalmologique A de RothschildRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Two measuring methods of blood pressure

Arm Description

Outcomes

Primary Outcome Measures

Occurence of intracranial hemorrhagic complications

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03359434

First Posted

November 27, 2017

Last Updated

July 6, 2023

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

1. Study Identification

Unique Protocol Identification Number

NCT03359434

Brief Title

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

Acronym

BP-METROLOGY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 5, 2018 (Actual)

Primary Completion Date

December 4, 2023 (Anticipated)

Study Completion Date

December 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Stroke, Blood Pressure, Cerebral Hemorrhage

Keywords

Acute Stroke, Blood Pressure, Cerebral Hemorrhage

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

355 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Two measuring methods of blood pressure

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Clearsight device (Edwards) around the finger

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Intermittent blood pressure measurements with cuff.

Intervention Description

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

Primary Outcome Measure Information:

Title

Occurence of intracranial hemorrhagic complications

Description

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

Time Frame

36 hours after baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Occlusion of internal carotid arteries or proximal middle cerebral arteries (segment M1). Reperfusion after a thrombectomy procedure (defined by a 2b-3 Thrombolysis In Cerebral Infarction (TICI) score). Exclusion Criteria: Per-procedure hemorrhagic complications (prior to reperfusion) Known pregnancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amélie Yavchitz, MD PhD

Phone

01.48.03.64.54

Ext

+33

ayavchitz@for.paris

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MAZIGHI Mikael, MD PhD

Organizational Affiliation

Fondation Ophtalmologique A. de Rothschild

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondation Ophtalmologique A de Rothschild

City

Paris

ZIP/Postal Code

75019

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mikael MAZIGHI, MD PhD

mmazighi@for.paris

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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