Intracranial PressureMERCURYNCT06101537
Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury
An observational study of Intracranial Pressure and Brain Injuries, Traumatic, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The goal of this prospective, multicenter, observational, cohort trail is to explore the pattern of brain temperature-brain pressure association in acute brain injury and to clarify its predictive value for prognosis and neurological function 30 days after acute brain injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intracranial Pressure, Brain Injuries, Traumatic, Subarachnoid Hemorrhage
- What is being tested?
- Brain temperature-pressure monitoring
- Type of treatment
- Medical device
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2024to 24 Jul 2025
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to severe acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, and craniocerebral trauma from 20 centers with intracranial pressure monitoring during treatment, which allows continuous recording of brain temperature-brain pressure data.
Who may be able to join
- Adults, male or female, 18 to 65 years of age;
- Acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, or craniocerebral trauma;
- Glasgow Coma Scale (GCS) score of 3-12;
- Have undergone intracranial pressure monitoring probe placement, which allows continuous recording of brain temperature and pressure data;
- Signed informed consent.
Who cannot join
- GCS ≥13 points;
- Patients with concomitant intracranial infections, cerebral ischemia, congenital malformations, autoimmune encephalitis, or craniocerebral tumors;
- At the time of onset, there was a combination of systemic malignant tumor, acute stage of major systemic organ disease, or stage of functional decompensation;
- Maternity;
- Undergoing experimental drug or instrumental trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury：a Multicenter Prospective Cohort Study, MERCURY
The goal of this prospective, multicenter, observational, cohort trail is to explore the pattern of brain temperature-brain pressure association in acute brain injury and to clarify its predictive value for prognosis and neurological function 30 days after acute brain injury.
Read the detailed description
Temperature abnormalities have long been recognized as signs of disease. Brain temperature, as part of body temperature, reflects body temperature and brain metabolism during physiologic states. There is growing evidence that brain cell function is unequivocally temperature dependent and that brain temperature after brain injury cannot be reliably predicted by core body temperature. Brain temperature is therefore increasingly becoming an important alternative to brain pressure, enabling patients with a variety of brain injuries to benefit from continuous brain temperature monitoring. Meanwhile, the correlation between intracranial pressure, which is currently the most widely used indicator in clinical practice, and brain temperature in patients with acute brain injury remains unelucidated. Whether the correlation between brain temperature and intracranial pressure has certain patterns and rhythms that can indirectly reflect the brain function of patients under the condition of injury and have a predictive value for clinical outcomes is the main research objective of this study. It is hoped that the present study will explore the correlation between brain temperature and brain pressure and the pattern of the correlation, as well as its impact on clinical prognosis. It provides a more precise target for intervention to further improve the prognosis of patients with acute brain injury.
- Conditions
- Intracranial Pressure, Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Cerebral Hemorrhage
- Being tested
- Brain temperature-pressure monitoring
- Keywords
- brain temperature monitoring, intracranial pressure monitoring, severe brain injury, subarachnoid hemorrhage, cerebral hemorrhage, traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Cerebral Hemorrhage, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain temperature-pressure monitoringDevice
An intracranial pressure monitoring device that continuously records brain temperature-pressure data was used during treatment.
| Study group | Role | What they receive |
|---|---|---|
| Brain temperature-pressure monitoring group | From a neurointensive care unit with intracranial pressure monitoring during treatment, which allows continuous recording of brain temperature-pressure data, in patients with moderate and severe acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, and craniocerebral trauma. Receives: Device: Brain temperature-pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Patterns of brain temperature-brain pressure in acute brain injury
By using a brain temperature-pressure monitoring device, the correlation was analyzed by continuously recording brain temperature-pressure data and plotting time-brain temperature and time-brain pressure curves in patients with moderate and severe acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, and craniocerebral trauma.
Measured: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
Predictive value of brain temperature-brain pressure correlation patterns on prognosis and neurological function in patients with acute brain injury
Predictive value of the brain temperature-brain pressure correlation patterns on the prognosis and neurological function of patients after acute brain injury as clarified by patients' Extended Glasgow Outcome Scale (GOSE) (an 8-point scale, ranging from death to "upper good recovery" ).
Measured: 30 days after acute brain injury
Secondary outcomes (4)
Rhythmic patterns of brain temperature in acute brain injury
To explore the rhythmic pattern of brain temperature in acute brain injury by using a brain temperature-pressure monitoring device, obtaining continuous brain temperature data, and plotting the brain temperature-time curve.
Measured: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
Predictive value of brain temperature rhythmic patterns on prognosis and neurological function in patients with acute brain injury
Predictive value of the brain temperature rhythmic patterns on the prognosis and neurological function of patients after acute brain injury as clarified by patients' Extended Glasgow Outcome Scale (GOSE) (an 8-point scale, ranging from death to "upper good recovery" )
Measured: 30 days after acute brain injury
Differences in brain temperature-brain pressure correlation patterns by injury type
By using a brain temperature-brain pressure monitoring device, brain temperature-brain pressure data were continuously recorded in patients with moderate and severe acute brain injuries due to subarachnoid hemorrhage, cerebral hemorrhage, and craniocerebral trauma. And time-brain temperature and time-brain pressure curves were plotted to analyze the differences between different injury types.
Measured: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
Number of participants with brain temperature-pressure-related adverse events
After obtaining the predictive value of the brain temperature-pressure correlation patterns for prognosis and neurological function in patients with acute brain injury, the number of participants with associated adverse events was assessed by CTCAE v4.0.
Measured: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start15 Feb 2024
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
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 Intracranial PressureStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoyi Gao, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101537
- Sponsor's protocol ID
- HX-B-2023067
- Acronym
- MERCURY
- Status last verified
- Feb 2026
- First submitted
- 18 Oct 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weng WJ, Yang C, Huang XJ, Zhang YM, Liu JF, Yao JM, Zhang ZH, Wu XS, Mei T, Zhang CD, Jia J, Shi XF, Mao Q, Feng JF, Gao GY, Jiang JY. Effects of Brain Temperature on the Outcome of Patients with Traumatic Brain Injury: A Prospective Observational Study. J Neurotrauma. 2019 Apr 1;36(7):1168-1174. doi: 10.1089/neu.2018.5881. Epub 2018 Oct 10.
PubMed 30215286
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury：a Multicenter Prospective Cohort Study, MERCURY
- ClinicalTrials.gov ID
- NCT06101537
- Acronym / sponsor ID
- MERCURY / HX-B-2023067
- Conditions
- Intracranial Pressure, Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Cerebral Hemorrhage
- Keywords
- brain temperature monitoring, intracranial pressure monitoring, severe brain injury, subarachnoid hemorrhage, cerebral hemorrhage, traumatic brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 26 Oct 2023 (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 goal of this prospective, multicenter, observational, cohort trail is to explore the pattern of brain temperature-brain pressure association in acute brain injury and to clarify its predictive value for prognosis and neurological function 30 days after acute brain injury.
Detailed description
Temperature abnormalities have long been recognized as signs of disease. Brain temperature, as part of body temperature, reflects body temperature and brain metabolism during physiologic states. There is growing evidence that brain cell function is unequivocally temperature dependent and that brain temperature after brain injury cannot be reliably predicted by core body temperature. Brain temperature is therefore increasingly becoming an important alternative to brain pressure, enabling patients with a variety of brain injuries to benefit from continuous brain temperature monitoring. Meanwhile, the correlation between intracranial pressure, which is currently the most widely used indicator in clinical practice, and brain temperature in patients with acute brain injury remains unelucidated. Whether the correlation between brain temperature and intracranial pressure has certain patterns and rhythms that can indirectly reflect the brain function of patients under the condition of injury and have a predictive value for clinical outcomes is the main research objective of this study. It is hoped that the present study will explore the correlation between brain temperature and brain pressure and the pattern of the correlation, as well as its impact on clinical prognosis. It provides a more precise target for intervention to further improve the prognosis of patients with acute brain injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain temperature-pressure monitoring group | – | Device: Brain temperature-pressure monitoringFrom a neurointensive care unit with intracranial pressure monitoring during treatment, which allows continuous recording of brain temperature-pressure data, in patients with moderate and severe acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, and craniocerebral trauma. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, and craniocerebral trauma from 20 centers with intracranial pressure monitoring during treatment, which allows continuous recording of brain temperature-brain pressure data.
Key inclusion criteria (5 listed)
- Adults, male or female, 18 to 65 years of age;
- Acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, or craniocerebral trauma;
- Glasgow Coma Scale (GCS) score of 3-12;
- Have undergone intracranial pressure monitoring probe placement, which allows continuous recording of brain temperature and pressure data;
- Signed informed consent.
Key exclusion criteria (5 listed)
- GCS ≥13 points;
- Patients with concomitant intracranial infections, cerebral ischemia, congenital malformations, autoimmune encephalitis, or craniocerebral tumors;
- At the time of onset, there was a combination of systemic malignant tumor, acute stage of major systemic organ disease, or stage of functional decompensation;
- Maternity;
- Undergoing experimental drug or instrumental trials.
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 |
|---|---|---|
| Brain temperature-pressure monitoringAn intracranial pressure monitoring device that continuously records brain temperature-pressure data was used during treatment. | Device | Brain temperature-pressure monitoring group |
Primary outcome
Correlation Patterns of brain temperature-brain pressure in acute brain injury
Time frame: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
By using a brain temperature-pressure monitoring device, the correlation was analyzed by continuously recording brain temperature-pressure data and plotting time-brain temperature and time-brain pressure curves in patients with moderate and severe acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, and craniocerebral trauma.
Predictive value of brain temperature-brain pressure correlation patterns on prognosis and neurological function in patients with acute brain injury
Time frame: 30 days after acute brain injury
Predictive value of the brain temperature-brain pressure correlation patterns on the prognosis and neurological function of patients after acute brain injury as clarified by patients' Extended Glasgow Outcome Scale (GOSE) (an 8-point scale, ranging from death to "upper good recovery" ).
4 secondary outcomes
Rhythmic patterns of brain temperature in acute brain injury
Time frame: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
Predictive value of brain temperature rhythmic patterns on prognosis and neurological function in patients with acute brain injury
Time frame: 30 days after acute brain injury
Differences in brain temperature-brain pressure correlation patterns by injury type
Time frame: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
Number of participants with brain temperature-pressure-related adverse events
Time frame: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring
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 9 Feb 2026.
- Results publication: PubMed 30215286Weng WJ, Yang C, Huang XJ, Zhang YM, Liu JF, Yao JM, Zhang ZH, Wu XS, Mei T, Zhang CD, Jia J, Shi XF, Mao Q, Feng JF, Gao GY, Jiang JY. Effects of Brain Temperature on the Outcome of Patients with Traumatic Brain Injury: A Prospective Observational Study. J Neurotrauma. 2019 Apr 1;36(7):1168-1174. doi: 10.1089/neu.2018.5881. Epub 2018 Oct 10.
- Individual participant dataSharing planned: No
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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.
Guoyi Gao, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure and Brain Injuries, Traumatic, run by Beijing Tiantan Hospital at 1 site in China.
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 5 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 9 Feb 2026. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Correlation Patterns of brain temperature-brain pressure in acute brain injury (time frame: At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring). The study lists 2 primary outcomes in all. 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 NCT06101537, 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 9 Feb 2026.