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

Primary Purpose

Acute Cerebrovascular Accident

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Individualized blood pressure

Standard blood pressure

About this trial

This is an interventional other trial for Acute Cerebrovascular Accident focused on measuring Acute ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Blood pressure management, Brain infarction, Endovascular procedure, Thrombectomy, Blood pressure, Low blood pressure, Hemodynamic, Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Fondation Adolphe de RothschildRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Number of patient with a favorable functional outcome at 3 months

Rankin score less than 3

Secondary Outcome Measures

Full Information

NCT ID

NCT04352296

First Posted

April 10, 2020

Last Updated

September 22, 2023

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Collaborators

Ministry of Health, France

1. Study Identification

Unique Protocol Identification Number

NCT04352296

Brief Title

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

Acronym

DETERMINE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 8, 2021 (Actual)

Primary Completion Date

September 18, 2023 (Actual)

Study Completion Date

November 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Collaborators

Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

432 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Individualized blood pressure

Intervention Description

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

Intervention Name(s)

Standard blood pressure

Intervention Description

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 Outcome Measure Information:

Title

Number of patient with a favorable functional outcome at 3 months

Description

Rankin score less than 3

Time Frame

3 months visit

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

woman and man

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amélie Yavchitz

Phone

+33148036454

ayavchitz@for.paris

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Dr Maier

Organizational Affiliation

Hopital Fondation A de Rothschild

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Etienne Dr Gayat

Organizational Affiliation

Hôpital Lariboisière, AP-HP

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Morgan Dr Leguen

Organizational Affiliation

Hôpital Foch

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Russel Dr Chabanne

Organizational Affiliation

CHU Gabriel Montpied

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Baptiste Dr Balanca

Organizational Affiliation

Hospices Civils de Lyon, Hôpital Pierre Wertheimer

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Benoit Pr Tavernier

Organizational Affiliation

Hôpital Roger Salengro, Lille

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Thomas Pr Geeraerts

Organizational Affiliation

Hôpital Purpan, CHU Toulouse

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Benjamin Pr Gory

Organizational Affiliation

"Centre Hospitalier Régional Universitaire (Nancy)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Grégoire Dr Boulouis

Organizational Affiliation

Centre Hospitalier Régional Universitaire de Tours

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Vincent Pr Degos

Organizational Affiliation

La Pitié Salpêtrière (APHP)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Gaultier Dr Marnat

Organizational Affiliation

CHU de Bordeaux, Hôpital Pellegrin

Official's Role

Study Chair

Facility Information:

Facility Name

Hôpital Fondation Adolphe de Rothschild

City

Paris

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amélie Yavchitz

First Name & Middle Initial & Last Name & Degree

Benjamin Maier

12. IPD Sharing Statement

Citations:

PubMed Identifier

35883180

Citation

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.

Results Reference

derived

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

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