Research on the Brain Death Determination in China

Completed

• Conditions: Brain Death; Evoked Potential; Quality Control; Electroencephalogram; TCD

• Registration Number: NCT05903443
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

Purpose China has a population of 1.4 billion and an enormous medical expenditure burden, and Chinese traditional culture has a long history. It takes time to recognize and accept the concept of brain death (BD) as death. Promoting brain death determination (BDD) and rationally allocating medical resources have become major national policy issues. To identify the safest and most reliable ancillary tests needed if the clinical examination is incomplete.

Method The technical group of the Brain Injury Evaluation Quality Control Center of the National Health Commission retrieved coma cases registered from 2013 to 2019. According to clinical criteria for Brain Death Determination (BDD), the patients were divided into two groups: a brain-death (BD) group and a non-BD group. The BD group was divided into a complete brain death with no doubt group (BD1 group) and an incomplete brain death with doubt group (BD2 group). Depending on the site of the brain injury, the accuracy of BDD was evaluated using the independent ancillary test or combined ancillary tests. Data from the BQCC/NHC database and yearbook were obtained, and data analysis and status comparison were conducted on six practical activities: organizational system construction, standard and specification formulation, case quality control, professional skills training, scientific research publicity and education, and international communication.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2023-04-15
• Status Verified: 2023-05
• Study Completion: 2023-05-15
• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-06-05
• Last Update Submitted: 2023-06-05
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1974

Inclusion Criteria

• All cases met the clinical criteria for BD, involving deep coma (Glasgow Coma Scale (GCS)=2T), the absence of brainstem reflexes (pupillary light reflex, corneal reflex, oculocephalogyric reflex, oculovestibular reflex, and cough reflex), and spontaneous respiration. Ancillary tests were completed for all patients.

Exclusion Criteria

• Does not meet BD clinical evaluation criteria. Ancillary tests were not implemented.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sensitivity	1 month	The sensitivity of BDD was evaluated using the independent ancillary test and combined ancillary tests
specificity	1 month	The specificity of BDD was evaluated using the independent ancillary test and combined ancillary tests

Trial Locations

Locations (1)

Xuanwu Hospital; 🇨🇳 Beijing, Beijing, China