Research on the Brain Death Determination in China (RBDDC)

Research on the Brain Death Determination and Quality Controlin Chinese Adults

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.

Study Overview

• Status: Completed
• Conditions: Brain Death; Electroencephalogram; Evoked Potential; TCD; Quality Control
• Intervention / Treatment: Diagnostic test: ancillary tests

• Study Type: Observational
• Enrollment (Actual): 1974

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Coma cases registered by the National Brain Death Determination Quality Control Demonstration Hospital (BDQCH) in the BQCC/NHC from 2013 to 2019 were retrieved.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BD group; All cases met the (brain death) BD clinical evaluation criteria, which were as follows: the cause of coma was known; exclusion of reversible coma; deep coma, Glasgow coma scale (GCS) = 2T; absence of five brain stem reflexes (pupillary light reflex, corneal reflex, oculocephalogyric reflex, oculovestibular reflex, and cough reflex); and no spontaneous respiration. Furthermore, according to whether the apnea test (AT) data were missing (implemented or completed), the patients were divided into the BD1 group (no AT missing group) and BD2 group (AT missing group).	Diagnostic test: ancillary tests; electroencephalogram, short latency somatosensory evoked potential, transcranial Doppler
non-BD group; All cases were from BDQCHs and fulfilled the criteria for coma (GCS of 3-5 points), but did not meet the clinical criteria for BD, such as retaining the brainstem reflex or having spontaneous respiration. For coma cases, all assessment items, specifications of technical operations, assessment steps, and evaluators were conducted in accordance with the requirements for BDD. Cases with coma were then submitted to the BQCC/NHC quality control system.	Diagnostic test: ancillary tests; electroencephalogram, short latency somatosensory evoked potential, transcranial Doppler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity	The sensitivity of BDD was evaluated using the independent ancillary test and combined ancillary tests	1 month
specificity	The specificity of BDD was evaluated using the independent ancillary test and combined ancillary tests	1 month

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Coma; Death; Brain Death
• Other Study ID Numbers: 2014004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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