Subarachnoid Hemorrhage Clinical Trial
— MERCURYOfficial 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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Adults, male or female, 18 to 65 years of age; 2. Acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, or craniocerebral trauma; 3. Glasgow Coma Scale (GCS) score of 3-12; 4. Have undergone intracranial pressure monitoring probe placement, which allows continuous recording of brain temperature and pressure data; 5. Signed informed consent. Exclusion Criteria: 1. GCS =13 points; 2. Patients with concomitant intracranial infections, cerebral ischemia, congenital malformations, autoimmune encephalitis, or craniocerebral tumors; 3. 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; 4. Maternity; 5. Undergoing experimental drug or instrumental trials. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital |
China,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring | |
Primary | 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" ). | 30 days after acute brain injury | |
Secondary | 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. | At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring | |
Secondary | 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" ) | 30 days after acute brain injury | |
Secondary | 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. | At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring | |
Secondary | 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. | At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring |
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