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Completed

NCT Number: NCT04352296

Effect of Individualized Versus Standard Bp Management During MT 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized blood pressure

Procedure

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

Standard blood pressure

Procedure

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).

Primary outcomes

  1. Number of patient with a favorable functional outcome at 3 months

    Time frame: 3 months visit

    Rankin score less than 3

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: DETERMINE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 20, 2020
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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