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NCT03359434 Clinical Trial

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

Blood Pressure Clinical Trial

— BP-METROLOGY  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03359434
Other study ID # MMI_2017_12
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 5, 2018
Est. completion date December 4, 2024

Study information
Verified date December 2023
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 355
Est. completion date December 4, 2024
Est. primary completion date December 17, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Fondation Ophtalmologique A de Rothschild Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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