Brain InjuriesPhase 4NEUROTHERMNCT03648021
The Effect of Paracetamol on Brain Temperature
A Phase 4 study testing Paracetamol in people with Brain Injuries, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2018to 26 May 2022
- Phase
- Phase 4
- 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
- 18-year or older patients
- Patient hospitalized in neuro-critical care for:
- Arachnoid hemorrhage
- Intra parenchymatous hematoma
- stroke
- Acute brain Severe injury
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NEUROTHERM: The Effect of Paracetamol on Brain Temperature in Acute Brain Injury in a Neuro Critical Care Unit: A Randomized Controlled Trial
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.
- Conditions
- Brain Injuries
- Being tested
- Paracetamol, Placebo
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called acetaminophen
>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
PlaceboDrug
100mL of chlorure de sodium 0.9% administred intravenously. 1 dose
| Study group | Role | What they receive |
|---|---|---|
| paracetamol (acetaminophen) | Active comparator | patient will receive1 gramme of paracetamol intravenously Receives: Drug: Paracetamol |
| Placebo | Placebo comparator | patient will receive 100 ml of chlorure de sodium 0,9% intravenously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
measurement of intracerebral temperature in degrees
Measured: Six hours after administration of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start3 May 2018
- Primary completion26 May 2022
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Marine de Mesmay, MD, Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648021
- Sponsor's protocol ID
- MDY_2017_19
- Acronym
- NEUROTHERM
- Status last verified
- Jul 2023
- First submitted
- 3 Aug 2018
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Mesmay M, Geral L, Gregoire C, Roy M, Welschbillig S, Le Cossec C, Engrand N. Effect of Paracetamol on Cerebral Temperature in Febrile Brain-Injured Patients. The NEUROTHERM Study: A Randomized Controlled Pharmacodynamic Trial. Crit Care Med. 2026 Jan 1;54(1):108-118. doi: 10.1097/CCM.0000000000006951. Epub 2025 Nov 11.
PubMed 41217349
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEUROTHERM: The Effect of Paracetamol on Brain Temperature in Acute Brain Injury in a Neuro Critical Care Unit: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03648021
- Acronym / sponsor ID
- NEUROTHERM / MDY_2017_19
- Conditions
- Brain Injuries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 3 May 2018 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 27 Aug 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paracetamol (acetaminophen) | Active comparator | Drug: Paracetamolpatient will receive1 gramme of paracetamol intravenously |
| Placebo | Placebo comparator | Drug: Placebopatient will receive 100 ml of chlorure de sodium 0,9% intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18-year or older patients
- Patient hospitalized in neuro-critical care for:
- Arachnoid hemorrhage
- Intra parenchymatous hematoma
- stroke
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| ParacetamolAlso: acetaminophen>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 | Drug | paracetamol (acetaminophen) |
| Placebo100mL of chlorure de sodium 0.9% administred intravenously. 1 dose | Drug | Placebo |
Primary outcome
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)
Time frame: Six hours after administration of treatment
measurement of intracerebral temperature in degrees
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 27 Jul 2023.
- Derived from this study: PubMed 41217349de Mesmay M, Geral L, Gregoire C, Roy M, Welschbillig S, Le Cossec C, Engrand N. Effect of Paracetamol on Cerebral Temperature in Febrile Brain-Injured Patients. The NEUROTHERM Study: A Randomized Controlled Pharmacodynamic Trial. Crit Care Med. 2026 Jan 1;54(1):108-118. doi: 10.1097/CCM.0000000000006951. Epub 2025 Nov 11.
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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.
Marine de Mesmay, MD principal investigator
Fondation Ophtalmologique Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol in people with Brain Injuries, 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 10 inclusion and 5 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 27 Jul 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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) (time frame: Six hours after administration of treatment). 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 NCT03648021, which also lists 1 linked publication.
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 27 Jul 2023.