Acute Cerebrovascular AccidentDETERMINENCT04352296
Effect of Individualized Versus Standard Bp Management During MT for Anterior Ischemic Stroke
A study testing Individualized blood pressure and Standard blood pressure in people with Acute Cerebrovascular Accident, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cerebrovascular Accident
- What is being tested?
- Individualized blood pressure and Standard blood pressure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2021to 16 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Individualized Versus Standard Blood Pressure Management During Mechanical Thrombectomy for Anterior Ischemic Stroke
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.
Read the 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
- Being tested
- Individualized blood pressure, Standard blood pressure
- Keywords
- Acute ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Blood pressure management, Brain infarction, Endovascular procedure, Thrombectomy, Blood pressure, Low blood pressure, Hemodynamic, Hypertension
- Medical subject headings
- Stroke, Ischemic Stroke, Brain Infarction, Hypotension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized blood pressureProcedure or surgery
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 pressureProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Procedure: Standard blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with a favorable functional outcome at 3 months
Rankin score less than 3
Measured: 3 months visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start8 Mar 2021
- Primary completion16 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Benjamin Dr Maier, Principal investigator, Hopital Fondation A de RothschildEtienne Dr Gayat, Study chair, Hopital LariboisièreMorgan Dr Leguen, Study chair, Hôpital FochRussel Dr Chabanne, Study chair, CHU Gabriel MontpiedBaptiste Dr Balanca, Study chair, Hospices Civils de Lyon, Hôpital Pierre WertheimerBenoit Pr Tavernier, Study chair, Hôpital Roger Salengro, LilleThomas Pr Geeraerts, Study chair, Hôpital Purpan, CHU ToulouseBenjamin Pr Gory, Study chair, "Centre Hospitalier Régional Universitaire (Nancy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352296
- Sponsor's protocol ID
- BMR_2020_12
- Acronym
- DETERMINE
- Status last verified
- Dec 2024
- First submitted
- 10 Apr 2020
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maier B, Gory B, Chabanne R, Tavernier B, Jacquens A, Balanca B, Pommier M, Le Guen M, Thion LA, Clariot S, Lapergue B, Guyot A, Eker OF, Bapteste L, Olivot JM, Calviere L, Julean G, Bourst P, Audibert G, Degos V, Dupont J, Robichon E, Escalard S, Desilles JP, Smajda S, Redjem H, Boisseau W, Al Raaisi A, Blanc R, Piotin M, Seners P, Delvoye F, Comby PO, Boursin P, Yavchitz A, Nekrouf C, Le Cossec C, Mazighi M, Gayat E; DETERMINE Investigators. Individualized vs Standard Blood Pressure Control During Thrombectomy for Ischemic Stroke: The DETERMINE Randomized Clinical Trial. Neurology. 2026 Sep 8;107(5):e218420. doi: 10.1212/WNL.0000000000218420. Epub 2026 Aug 12.
PubMed 42585603Maier 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.
PubMed 35883180
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Individualized Versus Standard Blood Pressure Management During Mechanical Thrombectomy for Anterior Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04352296
- Acronym / sponsor ID
- DETERMINE / BMR_2020_12
- Conditions
- Acute Cerebrovascular Accident
- Keywords
- Acute ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Blood pressure management, Brain infarction, Endovascular procedure, Thrombectomy, Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Ministry of Health, France
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Individualized blood pressureIndividualized 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. |
| Control group | Active comparator | Procedure: Standard blood pressureStandard 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized blood pressureIndividualized 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 or surgery | Experimental group |
| Standard blood pressureStandard 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). | Procedure or surgery | Control group |
Primary outcome
Number of patient with a favorable functional outcome at 3 months
Time frame: 3 months visit
Rankin score less than 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 42585603Maier B, Gory B, Chabanne R, Tavernier B, Jacquens A, Balanca B, Pommier M, Le Guen M, Thion LA, Clariot S, Lapergue B, Guyot A, Eker OF, Bapteste L, Olivot JM, Calviere L, Julean G, Bourst P, Audibert G, Degos V, Dupont J, Robichon E, Escalard S, Desilles JP, Smajda S, Redjem H, Boisseau W, Al Raaisi A, Blanc R, Piotin M, Seners P, Delvoye F, Comby PO, Boursin P, Yavchitz A, Nekrouf C, Le Cossec C, Mazighi M, Gayat E; DETERMINE Investigators. Individualized vs Standard Blood Pressure Control During Thrombectomy for Ischemic Stroke: The DETERMINE Randomized Clinical Trial. Neurology. 2026 Sep 8;107(5):e218420. doi: 10.1212/WNL.0000000000218420. Epub 2026 Aug 12.
- Derived from this study: PubMed 35883180Maier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Dr Maier principal investigator
Hopital Fondation A de Rothschild
Etienne Dr Gayat study chair
Hopital Lariboisière
Morgan Dr Leguen study chair
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized blood pressure and Standard blood pressure in people with Acute Cerebrovascular Accident, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient with a favorable functional outcome at 3 months (time frame: 3 months visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04352296, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.