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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Recruiting

CT.gov ID

NCT03359434

Collaborator

(none)

355

Enrollment

Location

Arm

71.9

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Stroke Blood Pressure Cerebral Hemorrhage	Device: Clearsight device (Edwards) around the finger Device: Intermittent blood pressure measurements with cuff.	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

355 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 5, 2018

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Two measuring methods of blood pressure	Device: Clearsight device (Edwards) around the finger Continuous measurement of blood pressure with the Clearsight device (Edwards) around the finger, within 24 hours after reperfusion: Device: Intermittent blood pressure measurements with cuff. Standard method: 35 blood pressure measurements with cuff within 24 hours after reperfusion

Arm

Intervention/Treatment

Experimental: Two measuring methods of blood pressure

Device: Clearsight device (Edwards) around the finger

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

Device: Intermittent blood pressure measurements with cuff.

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

Outcome Measures

Primary Outcome Measures

Occurence of intracranial hemorrhagic complications [36 hours after baseline]
number of intracranial hemorrhagic complications (symptomatic or asymptomatic) on brain scanner, evaluated with a double centralized blind reading

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).