NCT04352296

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 433 (actual)
• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Cerebrovascular Accident

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-03-08
• Primary completion: 2024-01-16
• Completion: 2024-01-16
• First posted: 2020-04-20
• Last updated: 2024-12-16

Locations

1 site across 1 country: France