Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury

NCT ID: NCT06101537

Last Updated: 2026-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-15

Study Completion Date

2025-07-24

Brief Summary

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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

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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

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Intracranial Pressure Brain Injuries, Traumatic Subarachnoid Hemorrhage Cerebral Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Brain temperature-pressure monitoring

Intervention Type DEVICE

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

Interventions

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Brain temperature-pressure monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guoyi Gao, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 30215286 (View on PubMed)

Other Identifiers

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HX-B-2023067

Identifier Type: -

Identifier Source: org_study_id

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