Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2018-05-03
2022-05-26
Brief Summary
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The investigators will measure brain temperature using a thermistor that will be connected to the intracranial pressure transducer.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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paracetamol (acetaminophen)
patient will receive1 gramme of paracetamol intravenously
Paracetamol
\>50kg: Paracetamol 1 gramme in a solution of 10mg/mL administred intravenously. 1 dose
\>50kg: Paracetamol 15mg/kg/dose in a solution 10mg/mL administred intravenously. 1 dose
Placebo
patient will receive 100 ml of chlorure de sodium 0,9% intravenously
Placebo
100mL of chlorure de sodium 0.9% administred intravenously. 1 dose
Interventions
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Paracetamol
\>50kg: Paracetamol 1 gramme in a solution of 10mg/mL administred intravenously. 1 dose
\>50kg: Paracetamol 15mg/kg/dose in a solution 10mg/mL administred intravenously. 1 dose
Placebo
100mL of chlorure de sodium 0.9% administred intravenously. 1 dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient hospitalized in neuro-critical care for:
* Arachnoid hemorrhage
* Intra parenchymatous hematoma
* stroke
* Acute brain Severe injury
* Post-operative complication of an act of neurosurgery or programmed neuroradiology
* Sedation and mechanical ventilation planned \> 2 days
* Monitoring of intracranial temperature and pressure by intraparenchymal sensor (Sophysa®)
* Brain temperature \> 38.5°C for more than 30 minutes
Exclusion Criteria
* Severe hepatocellular insufficiency (ASAT or ALAT \> 5N, or bilirubin \> 2N)
* Pharmacological intervention (administration of corticosteroids, NSAIDs or paracetamol) or physical intervention (external cooling technique) that may influence temperature in the last 6 hours.
* Pregnant or breastfeeding women
* Previous participation in this study
18 Years
ALL
No
Sponsors
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Fondation Ophtalmologique Adolphe de Rothschild
NETWORK
Responsible Party
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Principal Investigators
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Marine de Mesmay, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Ophtalmologique Adolphe de Rothschild
Locations
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Hôpital Fondation Adolphe de Rothschild
Paris, , France
Countries
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Other Identifiers
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MDY_2017_19
Identifier Type: -
Identifier Source: org_study_id
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