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

NCT ID: NCT04352296

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 433 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2024-01-16

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.

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

Individualized blood pressure

Intervention Type: 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

Control group

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).

Group Type: ACTIVE_COMPARATOR

Standard blood pressure

Intervention Type: 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).

Interventions

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

Intervention Type: 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).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Dr Maier

Role: PRINCIPAL_INVESTIGATOR

Hopital Fondation A de Rothschild

Etienne Dr Gayat

Role: STUDY_CHAIR

Hôpital Lariboisière, AP-HP

Morgan Dr Leguen

Role: STUDY_CHAIR

Hôpital Foch

Russel Dr Chabanne

Role: STUDY_CHAIR

CHU Gabriel Montpied

Baptiste Dr Balanca

Role: STUDY_CHAIR

Hospices Civils de Lyon, Hôpital Pierre Wertheimer

Benoit Pr Tavernier

Role: STUDY_CHAIR

Hôpital Roger Salengro, Lille

Thomas Pr Geeraerts

Role: STUDY_CHAIR

Hôpital Purpan, CHU Toulouse

Benjamin Pr Gory

Role: STUDY_CHAIR

"Centre Hospitalier Régional Universitaire (Nancy)

Grégoire Dr Boulouis

Role: STUDY_CHAIR

Centre Hospitalier Régional Universitaire de Tours

Vincent Pr Degos

Role: STUDY_CHAIR

La Pitié Salpêtrière (APHP)

Gaultier Dr Marnat

Role: STUDY_CHAIR

CHU de Bordeaux, Hôpital Pellegrin

Locations

Hôpital Fondation Adolphe de Rothschild

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35883180 (View on PubMed)

Other Identifiers

BMR_2020_12

Identifier Type: -

Identifier Source: org_study_id