Correlation Patterns of Brain Temperature-Pressure in Acute Brain Injury

NCT06101537 | Completed DMC

• 1 other identifier: HX-B-2023067
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Pressure; Cerebral Hemorrhage; Brain Injuries, Traumatic; Subarachnoid Hemorrhage

Keywords

brain temperature monitoring; intracranial pressure monitoring; severe brain injury; subarachnoid hemorrhage; cerebral hemorrhage; traumatic brain injury

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Rhythmic patterns of brain temperature in acute brain injury

  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

  30 days after acute brain injury

• Differences in brain temperature-brain pressure correlation patterns by injury type

  At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring

• Number of participants with brain temperature-pressure-related adverse events

  At baseline and on days 1-7 after receiving brain temperature-brain pressure monitoring

Study Arms (1)

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.

Device: Brain temperature-pressure monitoring

Interventions

Brain temperature-pressure monitoring DEVICE

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

Brain temperature-pressure monitoring group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Related 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. J Neurotrauma. 2019 Apr 1;36(7):1168-1174. doi: 10.1089/neu.2018.5881. Epub 2018 Oct 10.

  PMID: 30215286 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guoyi Gao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 26, 2023
• Study Start: February 15, 2024
• Primary Completion: July 24, 2025
• Study Completion: July 24, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)