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

NCT04352296 | Completed

• 1 other identifier: BMR_2020_12
• Study Type: interventional
• Target: 433
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cerebrovascular Accident

Keywords

Acute ischemic stroke; Large vessel occlusion; Mechanical thrombectomy; Blood pressure management; Brain infarction; Endovascular procedure; Thrombectomy; Blood pressure; Low blood pressure; Hemodynamic; Hypertension

Outcome Measures

Primary Outcomes (1)

• Number of patient with a favorable functional outcome at 3 months

  Rankin score less than 3

  3 months visit

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

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

Experimental group

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).

Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: woman and man
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Hôpital Fondation Adolphe de Rothschild

Paris, France

Location

Related Publications (1)

• Maier B, Gory B, Chabanne R, Tavernier B, Balanca B, Audibert G, Thion LA, Le Guen M, Geeraerts T, Calviere L, Degos V, Lapergue B, Richard S, Djarallah A, Mophawe O, Boursin P, Le Cossec C, Blanc R, Piotin M, Mazighi M, Gayat E; DETERMINE Investigators. Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial. Trials. 2022 Jul 26;23(1):598. doi: 10.1186/s13063-022-06538-9.

  PMID: 35883180 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Brain Infarction; Hypotension; Hypertension

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Benjamin Dr Maier

  Hopital Fondation A de Rothschild

  PRINCIPAL INVESTIGATOR

• 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)

  STUDY CHAIR

• Gaultier Dr Marnat

  CHU de Bordeaux, Hôpital Pellegrin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 20, 2020
• Study Start: March 8, 2021
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)