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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Recruiting

CT.gov ID

NCT04352296

Collaborator

Ministry of Health, France (Other)

432

Enrollment

Location

Arms

44.5

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Cerebrovascular Accident	Procedure: Individualized blood pressure Procedure: Standard blood pressure	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

432 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 8, 2021

Anticipated Primary Completion Date :

Sep 8, 2023

Anticipated Study Completion Date :

Nov 20, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Number of patient with a favorable functional outcome at 3 months [3 months visit]
Rankin score less than 3

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benjamin Maier	Paris		France

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild
Ministry of Health, France

Investigators

Principal Investigator: Benjamin Dr Maier, Hopital Fondation A de Rothschild
Study Chair: Etienne Dr Gayat, Hôpital Lariboisière, AP-HP
Study Chair: Morgan Dr Leguen, Hôpital 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)