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

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.

Conditions

• Acute Cerebrovascular Accident

Interventions

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

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).

Sponsors & Collaborators

• Ministry of Health, France

  collaborator OTHER_GOV

• Fondation Ophtalmologique Adolphe de Rothschild

  lead NETWORK

Principal Investigators

• Benjamin Dr Maier · Hopital Fondation A de Rothschild

• Etienne Dr Gayat · Hôpital Lariboisière, AP-HP

• Morgan Dr Leguen · Hôpital Foch

• Russel Dr Chabanne · CHU Gabriel Montpied

• Baptiste Dr Balanca · Hospices Civils de Lyon, Hôpital Pierre Wertheimer

• Benoit Pr Tavernier · Hôpital Roger Salengro, Lille

• Thomas Pr Geeraerts · Hôpital Purpan, CHU Toulouse

• Benjamin Pr Gory · "Centre Hospitalier Régional Universitaire (Nancy)

• Grégoire Dr Boulouis · Centre Hospitalier Régional Universitaire de Tours

• Vincent Pr Degos · La Pitié Salpêtrière (APHP)

• Gaultier Dr Marnat · CHU de Bordeaux, Hôpital Pellegrin

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-08

Primary Completion

2024-01-16

Completion

2024-01-16

Countries

• France

Study Locations