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

Acute Cerebrovascular Accident Clinical Trial

— DETERMINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04352296
• Other study ID #: BMR_2020_12
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: November 20, 2024

Study information

• Verified date: September 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amélie Yavchitz
• Phone: +33148036454
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: November 20, 2024
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Cerebrovascular Accident
• Ischemic Stroke
• Stroke

Intervention

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
• 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).

Locations

Country	Name	City	State
France	Hôpital Fondation Adolphe de Rothschild	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient with a favorable functional outcome at 3 months	Rankin score less than 3	3 months visit