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

NCT06505213 | Not Yet Recruiting

• 1 other identifier: 2024070747
• Study Type: observational
• Target: 490
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Neuromonitoring Pattern

  3-5 days

• Neuromonitoring and Short Term Outcome

  28 days

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically Ill, Acute Brain Injury Adult Patients.

You may qualify if:

• Must be 18 years of age or older.
• Diagnosed with Traumatic Brain Injury (TBI) or has suffered from acute brain injury due to intracranial hemorrhage or subarachnoid hemorrhage.
• 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).
• Occurs within 48 hours of admission, where the patient does not open eyes and motor score drops to 5 or below.

You may not qualify if:

• Patients who were not admitted to the Intensive Care Unit (ICU) are excluded.
• Patients with forms of acute brain injury other than those specified (TBI, intracranial hemorrhage, subarachnoid hemorrhage) are also excluded.
• Patients with known severe liver or kidney dysfunction are excluded.
• 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.
• Patients who had a Modified Rankin Scale greater than 2 before the onset of the current illness.
• Patients with a history of congenital or acquired hemorrhagic diseases, coagulation factor deficiencies, or thrombocytopenic disorders.
• Pregnant or lactating women, as well as those planning to become pregnant within the next 90 days.
• Patients with severe psychiatric disorders or dementia who are unable to provide informed consent or complete follow-up requirements.
• Patients who have participated in other interventional clinical trials within 30 days prior to randomization, or who are currently participating in other clinical research.
• Any other reasons that the researcher deems unsuitable for participation in this trial.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Le Zhang

CONTACT

+8613973187150; zlzdzlzd@csu.edu.cn

Ye Li

CONTACT

+8619967131289; 17670516318@163.com

Study Design

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

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 17, 2024

Record last verified: 2024-07