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

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ClinicalTrials.gov Identifier: NCT03359434
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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. Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 355 participants
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 : December 5, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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




Primary Outcome Measures :
  1. Occurence of intracranial hemorrhagic complications [ Time Frame: 36 hours after baseline ]
    number of intracranial hemorrhagic complications (symptomatic or asymptomatic) on brain scanner, evaluated with a double centralized blind reading



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359434


Contacts
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Contact: Laurence SALOMON, MD PhD 01.48.03.64.31 ext +33 lsalomon@for.paris

Locations
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France
Fondation Ophtalmologique A de Rothschild Recruiting
Paris, France, 75019
Contact: Mikael MAZIGHI, MD PhD       mmazighi@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: MAZIGHI Mikael, MD PhD Fondation Ophtalmologique A. de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03359434     History of Changes
Other Study ID Numbers: MMI_2017_12
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Acute Stroke
Blood Pressure
Cerebral Hemorrhage
Additional relevant MeSH terms:
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Stroke
Intracranial Hemorrhages
Cerebral Hemorrhage
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes