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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06101537
Other study ID # HX-B-2023067
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 15, 2024
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Beijing Tiantan Hospital
Contact Liang Wu, MD
Phone 15001333582
Email wuliang@bjtth.org
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Device:
Brain temperature-pressure monitoring
An intracranial pressure monitoring device that continuously records brain temperature-pressure data was used during treatment.

Locations

Country Name City State
China Beijing Tiantan Hospital, Capital Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

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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