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Clinical trial

NEUROTHERM: The Effect of Paracetamol on Brain Temperature in Acute Brain Injury in a Neuro Critical Care Unit: A Randomized Controlled Trial

ID
Name
MDY_2017_19
Description
The main objective of this study is to compare the effect of intravenous paracetamol administration on mean brain temperature (measured between H0 and H6) in patients with cerebral hyperthermia versus placebo. The investigators will measure brain temperature using a thermistor that will be connected to the intracranial pressure transducer.
Trial arms
Trial start
2018-05-03
Estimated PCD
2022-05-26
Trial end
2022-05-26
Status
Completed
Phase
Early phase I
Treatment
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
Arms:
paracetamol (acetaminophen)
Other names:
acetaminophen
Placebo
100mL of chlorure de sodium 0.9% administred intravenously. 1 dose
Arms:
Placebo
Size
100
Primary endpoint
Comparison of mean brain temperature measured between H0 and H6 following administration of treatment between the two groups (the group treated with paracetamol and the placebo group)
Six hours after administration of treatment
Eligibility criteria
Inclusion Criteria * 18-year or older patients * 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 * Known hypersensitivity to paracetamol or mannitol (excipient with known effect) * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-07-27

1 organization

1 product

1 drug

1 indication

Organization
Fondation Ophtalmologique Adolphe de Rothschild
Product
Paracetamol
Indication
Traumatic Brain Injury
Drug
Varlilumab