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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-520205-39-00 | EU Trial (CTIS) Number |
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The purpose of this study is to demonstrate the efficacy of early continuous intravenous infusion of hypertonic saline solution (HSS) to improve survival and independence in daily life activities (at 6 months) of patients with traumatic brain injury at high risk of intracranial hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic Saline Solution | Experimental | Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension) |
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| Standard | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic saline solution | Drug | Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of early continuous of HSS | Survival : number of patients still alive | 3 months |
| Efficacy of early continuous of HSS | Rate of moderate to no dependency in activities in daily living at 6 months is defined as a Barthel Index of independence in activities in daily living ≥ 61. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment of intracranial hypertension | Evolution of blood sodium level | 7 days |
| Treatment of intracranial hypertension | Evolution of blood chloride level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine ROQUILLY | Contact | +33 2 53 48 22 30 | antoine.roquilly@chu-nantes.fr | |
| Astrid GARREAU | Contact | +33 2 53 48 28 40 | astrid.garreau@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Not yet recruiting | Angers | France |
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Controlled, Single insulated with blinded assessment of the primary endpoint, Prospective
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| 7 days |
| Treatment of intracranial hypertension | Evolution of solute concentration in blood plasma | 7 days |
| Neurological recovery | Number of therapeutic interventions with the TIL (Therapeutic Intensity Level) scale. | 7 days |
| Neurological recovery | Survival : number of patients still alive | until 12 months |
| Quality of life | Score of EQ-5D-5L (5-level EuroQol-5D version) : minimum - maximal values: 1-5, higher scores mean a worse outcome. | until 12 month |
| Quality of life | Rates of patient living at home, at rehabilitation centers or at hospital | until 12 months |
| Anterograde amnesia | Galveston Orientation and Amnesia Test (G.O.A.T) : minimum - maximal values: 0-100, higher scores mean a better outcome. | until 6 months |
| Neurocognitive functioning | Montreal Cognitive Assessment (MOCA) : minimum - maximal values: 0-30, higher scores mean a better outcome. | 6 months |
| Neurological outcome | Glasgow Outcome Scale Extended (GOS-E) : minimum - maximal values: 1-8, higher scores mean a better outcome. | 6 months |
| Tolerance | Rates severe hypernatremia (Na> 160 mmol/L) | 1 month |
| Tolerance | Rates of acute kidney injury | 1 month |
| Tolerance | Number of thrombotic events | 1 month |
| Tolerance | Number of entral-pontine myelinolysis | 1 month |
| Cost-effectiveness analysis | Incremental cost-effectiveness ratio | 12 months |
| Genetic biomarkers | Single nucleotide polymorphism | 12 months |
| CHU de Brest | Not yet recruiting | Brest | France |
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| CHU Caen Normandie | Not yet recruiting | Caen | France |
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| CHU de Clermont- Ferrand | Not yet recruiting | Clermont-Ferrand | France |
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| Hôpital BEAUJON APHP | Not yet recruiting | Clichy | France |
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| CHU Henri Mondor APHP | Not yet recruiting | Créteil | France |
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| CH de Annecy Genevois | Not yet recruiting | Épagny | France |
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| CHU de Grenoble | Not yet recruiting | Grenoble | France |
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| CHU de Lille | Not yet recruiting | Lille | France |
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| HCL | Not yet recruiting | Lyon | France |
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| AP-HM | Not yet recruiting | Marseille | France |
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| CHU de Nancy | Not yet recruiting | Nancy | France |
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| CHU de Nantes | Recruiting | Nantes | France |
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| CHU de Nice | Not yet recruiting | Nice | France |
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| CHU Lariboisière, AP-HP | Not yet recruiting | Paris | France |
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| GHU Paris Cité | Not yet recruiting | Paris | France |
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| CHU de Poitiers | Not yet recruiting | Poitiers | France |
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| CHU de Rennes | Not yet recruiting | Rennes | France |
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| CHU de Rouen | Not yet recruiting | Rouen | France |
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| CHU de St- Etienne | Not yet recruiting | Saint-Etienne | France |
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| CHU de Strasbourg | Not yet recruiting | Strasbourg | France |
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| CHU de Toulouse | Not yet recruiting | Toulouse | France |
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| CHRU de Tours | Not yet recruiting | Tours | France |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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