Blood Pressure Measurement Methods and Prediction of Intracranial Hemorrhage After Thrombectomy in Stroke (BP-METROLOGY)
|ClinicalTrials.gov Identifier: NCT03359434|
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : August 13, 2019
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||355 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359434
|Contact: Laurence SALOMON, MD PhD||01.48.03.64.31 ext +firstname.lastname@example.org|
|Fondation Ophtalmologique A de Rothschild||Recruiting|
|Paris, France, 75019|
|Contact: Mikael MAZIGHI, MD PhD email@example.com|
|Principal Investigator:||MAZIGHI Mikael, MD PhD||Fondation Ophtalmologique A. de Rothschild|