NCT05903443

Research on the Brain Death Determination in China

Research on the Brain Death Determination and Quality Controlin Chinese Adults

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,974 (actual)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Death
• Electroencephalogram
• Evoked Potential
• TCD
• Quality Control

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ancillary tests	electroencephalogram, short latency somatosensory evoked potential, transcranial Doppler

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-04-15
• Completion: 2023-05-15
• First posted: 2023-06-15
• Last updated: 2023-06-15

Locations

1 site across 1 country: China