Predictors of Brain Death and Barriers to Organ Donation in a North African Intensive Care Units: A Multicenter Prospective Study on Severe Coma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Brain death incidence
研究概览
简要总结
The goal of this observational study was to identify factors associated with the progression to brain death in critically ill patients with severe brain injuries in Tunisian intensive care units (ICUs). The main questions it aimed to answer were:
What medical factors (e.g., type of brain injury, ICU stay duration) increased the likelihood of progressing to brain death in these patients?
What patient characteristics (e.g., age, comorbidities) influenced the risk of brain death?
What were the reasons behind low organ donation rates in Tunisia, including family refusal and hospital-level barriers?
Participants were:
Adults with severe coma (Glasgow Coma Scale ≤ 8) requiring mechanical ventilation in Tunisian ICUs.
Data were collected as part of routine medical care, including information about medical factors, patient characteristics, and family attitudes towards organ donation, without any additional interventions beyond standard care.
The study was conducted from November 2022 to November 2023 across three ICUs: Sahloul, Farhat Hached, and Mohamed Taher Maamouri Hospitals.
详细描述
Background
Brain death (BD) is a legally and medically recognized condition under which organ donation may occur. However, organ donation rates in Tunisia remain low compared to international benchmarks. There is a need to better understand the factors influencing the progression to brain death in ICU patients, as well as the sociocultural and institutional barriers to organ donation in this setting.
Objectives
This study aimed to:
Identify clinical predictors of brain death among critically ill patients with severe brain injuries
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years admitted to ICU with:
- •Severe coma (Glasgow Coma Scale ≤8)
- •Requiring mechanical ventilation
- •Primary diagnosis of:
- •Traumatic brain injury (TBI)
- •Hemorrhagic stroke
- •Other severe neurological conditions (anoxic brain injury, etc.)
- •Potential organ donor status (for brain death subgroup):
- •Meets clinical brain death criteria (absent brainstem reflexes, apnea)
排除标准
- •Non-neurological terminal conditions: e.g., Advanced cancer
结局指标
主要结局
Brain death incidence
时间窗: 0-12 months
Proportion of patients progressing to brain death (clinical + CT angiography).
Family donation refusal rate
时间窗: At time of brain death confirmation (through study completion, an average of 1 year)
Percentage of families declining organ donation, with reasons
次要结局
- Multivariate analysis of brain death predictors(From ICU admission to outcome determination (up to 1 year))
研究者
Imen Slama
Principal Investigator
Faculty of Medicine, Sousse