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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patient with a favorable functional outcome at 3 months | Rankin score less than 3 | 3 months visit |
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Inclusion Criteria:
Exclusion Criteria:
woman and man
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Dr Maier | Hopital Fondation A de Rothschild | Principal Investigator |
| Etienne Dr Gayat | Hopital Lariboisière | 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Fondation Adolphe de Rothschild | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35883180 | Derived | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D020520 | Brain Infarction |
| D007022 | Hypotension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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). |
|
| La Pitié Salpêtrière (APHP) |
| Study Chair |
| Gaultier Dr Marnat | CHU de Bordeaux, Hôpital Pellegrin | Study Chair |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |