Effect of Individualized Versus Standard Bp Management During MT for Anterior Ischemic Stroke (DETERMINE)

Effect of Individualized Versus Standard Blood Pressure Management During Mechanical Thrombectomy for Anterior Ischemic Stroke

DETERMINE is a multicenter, prospective, randomised, open, blinded end-point assessed (PROBE) trial, to evaluate two approaches of blood pressure (BP) management during mechanical thrombectomy for acute ischemic stroke due to an anterior large vessel occlusion.

Study Overview

• Status: Recruiting
• Conditions: Acute Cerebrovascular Accident
• Intervention / Treatment: Procedure: Individualized blood pressure; Procedure: Standard blood pressure

Detailed Description

This study have to objective to evaluate the efficacy of an individualized BP control during mechanical thrombectomy (regardless of the sedation modality), by maintaining a mean arterial pressure (MAP) within 10% of the first MAP measured in the angiography suit, compared to the standard BP management, on the 3-month functional outcome.

• Study Type: Interventional
• Enrollment (Estimated): 432
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amélie Yavchitz; Phone Number: +33148036454; Email: ayavchitz@for.paris

Study Locations

• France
  • Paris, France
    • Recruiting
    • Hôpital Fondation Adolphe de Rothschild
    • Contact: Amélie Yavchitz
    • Principal Investigator: Benjamin Maier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >18 years old
• Acute ischemic stroke due to an anterior large vessel occlusion: occlusion of the M1 or M2 segments of the middle cerebral artery, anterior cerebral artery (A1 segment), intracranial internal carotid artery, or tandem occlusions.
• Indication for mechanical thrombectomy under general anesthesia or conscious sedation within the first 6 hours from symptoms onset or within the first 24 hours if DAWN or DEFUSE-3 criteria are met.
• Affiliation to social security assurance.

Exclusion Criteria:

• Contre-indication to mechanical thrombectomy
• Intubation or induction of general anaesthesia prior to randomization
• Acute ischemic strokes associated with a posterior circulation large vessel occlusion (basilar artery, vertebral artery, posterior cerebral artery)
• Intra-hospital onset of acute ischemic stroke, or secondary to a medical, interventional or surgical procedure (interventional cardiology, cardiac or vascular surgery) or any post-surgery ischemic stroke.
• Pre-existing neurological disability limiting neurological assessment at 3 months: mRS >2 at randomization.
• Contraindication to iodinated contrast agents
• Known pregnancy or breastfeeding woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Individualized BP management during mechanical thrombectomy with the administration of diluted norepinephrine (5-10 µg/ml) or nicardipine (1 mg/ml) or urpidil (5 mg/ml) to maintain the MAP within 10% of the first MAP measured in the angiography suit.	Procedure: Individualized blood pressure; Individualized blood pressure management during mechanical thrombectomy with the administration of diluted norepinephrine (5-10 µg/ml) or nicardipine (1 mg/ml) or urpidil (5 mg/ml) to maintain the MAP within 10% of the first MAP measured in the angiography suit
Active Comparator: Control group; Standard BP management based on international guidelines: Treatment of hypotension defined by a systolic blood pressure <140 mm Hg, and treatment of hypertension defined by a systolic blood pressure > 180 mm Hg or diastolic blood pressure >105 mm Hg) with usual treatments (norepinephrine, ephedrine or phenylephrine for hypotension; intravenous nicardipine or uradipil for hypertension).	Procedure: Standard blood pressure; Standard blood pressure management based on international guidelines: Treatment of hypotension defined by a systolic blood pressure <140 mm Hg, and treatment of hypertension defined by a systolic blood pressure > 180 mm Hg or diastolic blood pressure >105 mm Hg) with usual treatments (norepinephrine, ephedrine or phenylephrine for hypotension; intravenous nicardipine or uradipil for hypertension).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient with a favorable functional outcome at 3 months	Rankin score less than 3	3 months visit

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Benjamin Dr Maier, Hôpital Fondation A de Rothschild; Study Chair: Etienne Dr Gayat, Hôpital Lariboisière, AP-HP; Study Chair: Morgan Dr Leguen, Hopital Foch; Study Chair: Russel Dr Chabanne, CHU Gabriel Montpied; Study Chair: Baptiste Dr Balanca, Hospices Civils de Lyon, Hôpital Pierre Wertheimer; Study Chair: Benoit Pr Tavernier, Hôpital Roger Salengro, Lille; Study Chair: Thomas Pr Geeraerts, Hôpital Purpan, CHU Toulouse; Study Chair: Benjamin Pr Gory, "Centre Hospitalier Régional Universitaire (Nancy); Study Chair: Grégoire Dr Boulouis, Centre Hospitalier Régional Universitaire de Tours; Study Chair: Vincent Pr Degos, La Pitié Salpêtrière (APHP); Study Chair: Gaultier Dr Marnat, CHU de Bordeaux, Hôpital Pellegrin

Publications and helpful links

General Publications

• Maier B, Gory B, Chabanne R, Tavernier B, Balanca B, Audibert G, Thion LA, Le Guen M, Geeraerts T, Calviere L, Degos V, Lapergue B, Richard S, Djarallah A, Mophawe O, Boursin P, Le Cossec C, Blanc R, Piotin M, Mazighi M, Gayat E; DETERMINE Investigators. Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial. Trials. 2022 Jul 26;23(1):598. doi: 10.1186/s13063-022-06538-9.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): September 18, 2023
• Study Completion (Estimated): November 20, 2024

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Hemodynamic; Hypertension; Thrombectomy; Blood pressure; Acute ischemic stroke; Large vessel occlusion; Mechanical thrombectomy; Brain infarction; Low blood pressure; Endovascular procedure; Blood pressure management
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: BMR_2020_12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No