Multimodal Brain Monitoring as an Early Warning and Prognostic Tool for Acute Brain Injury

The primary aim of this study is to evaluate the effectiveness of multimodal brain monitoring technologies as both an early warning system and a prognostic tool in patients suffering from acute brain injuries. This research seeks to determine how effectively these tools can predict clinical outcomes and prevent complications by providing early alerts to healthcare professionals.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Brain Injury
• Intervention / Treatment: Other: no intervention

Detailed Description

Acute brain injury, including traumatic brain injury (TBI) and stroke, presents significant challenges in clinical management, primarily due to the complexity of the brain's response to injury and the critical timing required for effective intervention. Multimodal brain monitoring, which integrates various physiological data points like brain electrical activity, cerebral blood flow, and brain tissue oxygenation, offers a comprehensive view of a patient's cerebral status. This study builds on the premise that a better understanding and real-time monitoring of these variables can significantly improve patient outcomes by enabling timely and targeted interventions.

• Study Type: Observational
• Enrollment (Estimated): 490

Contacts and Locations

• Study Contact: Name: Le Zhang; Phone Number: +8613973187150; Email: zlzdzlzd@csu.edu.cn
• Study Contact Backup: Name: Ye Li; Phone Number: +8619967131289; Email: 17670516318@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Critically Ill, Acute Brain Injury Adult Patients.

Description

Inclusion Criteria

1. Must be 18 years of age or older.
2. Diagnosed with Traumatic Brain Injury (TBI) or has suffered from acute brain injury due to intracranial hemorrhage or subarachnoid hemorrhage.
3. Defined as an admission Glasgow Coma Scale (GCS) Eye Response score of 1 (unable to open eyes) and a GCS Motor Response score of ≤5 (unable to obey commands).
4. Occurs within 48 hours of admission, where the patient does not open eyes and motor score drops to 5 or below.

Exclusion Criteria

1. Patients who were not admitted to the Intensive Care Unit (ICU) are excluded.
2. Patients with forms of acute brain injury other than those specified (TBI, intracranial hemorrhage, subarachnoid hemorrhage) are also excluded.
3. Patients with known severe liver or kidney dysfunction are excluded.
4. Patients whose vital signs are extremely unstable after admission, with a very poor prognosis and considered unable to survive, and whose family has decided to forgo further treatment.
5. Patients who had a Modified Rankin Scale greater than 2 before the onset of the current illness.
6. Patients with a history of congenital or acquired hemorrhagic diseases, coagulation factor deficiencies, or thrombocytopenic disorders.
7. Pregnant or lactating women, as well as those planning to become pregnant within the next 90 days.
8. Patients with severe psychiatric disorders or dementia who are unable to provide informed consent or complete follow-up requirements.
9. Patients who have participated in other interventional clinical trials within 30 days prior to randomization, or who are currently participating in other clinical research.
10. Any other reasons that the researcher deems unsuitable for participation in this trial.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relation between multimodal brain monitoring parameters and outcome.	Association between advanced multimodal brain monitoring parameters of the first 48h of admission and six months functional outcome (Glasgow Outcome Score Extended)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuromonitoring Pattern	Describe multimodal neuromonitoring parameters variation and identify trends.	3-5 days
Neuromonitoring and Short Term Outcome	Association between advanced multimodal brain monitoring parameters and 28 days functional outcome (Glasgow Outcome Score Extended)	28 days

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: 2024070747

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No