Research on the Brain Death Determination in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1974 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of CTA on the Assessment of Brain Death

NCT04914039

Brain Death

UNKNOWN

Explore Biomarkers of Motor Neuron Disease/Frontal Dementia Spectrum Disease in China

NCT04961450

Amyotrophic Lateral Sclerosis Frontotemporal Dementia Motor Neuron Disease

ENROLLING_BY_INVITATION

Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression

NCT03417063

Ischemic Stroke Transient Ischemic Attack Intracranial Artery Stenosis

UNKNOWN

Functional MRI to Assess Brain Damage in Cardiac Arrest Patients

NCT05966389

Cardiac Arrest Brain Injuries

COMPLETED

Chinese Severe Brain Injury Trial

NCT06179836

Severe Brain Injury

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Death Electroencephalogram Evoked Potential TCD Quality Control

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

ancillary tests

Intervention Type DIAGNOSTIC_TEST

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.

ancillary tests

Intervention Type DIAGNOSTIC_TEST

electroencephalogram, short latency somatosensory evoked potential, transcranial Doppler

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ancillary tests

electroencephalogram, short latency somatosensory evoked potential, transcranial Doppler

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.