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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acute Stroke
• Blood Pressure
• Cerebral Hemorrhage
• Hemorrhage
• Intracranial Hemorrhages
• Stroke

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