Cluster Randomized Trial Evaluating the Implementation of a Evidence Based Checklist for the Management of Potential Organ Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,535
- 试验地点
- 65
- 主要终点
- Losses of potential donors due to cardiac arrest
研究概览
简要总结
This study consists in an cluster-randomized clinical trial involving near 60 Brazilian intensive care units (ICUs) with a high notification rate of potential donors of organs and tissues. ICUs will be randomized in a 1:1 ratio to manage potential organ donors through the use of a evidence-based checklist or to manage potential organ donors according usual care. The primary outcome is the rate of losses of potential donors due to cardiac arrest. Secondary outcome measures include number of effective organ donors and number of organs recovery per effective donor. The first subject was enrolled on June 20, 2018.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ICUs reporting at least 10 potential valid donors (without clinical contraindications for donation) per year
- •For potential donor:
- •Age of 14 years or older
- •Suspected brain death after the first clinical test
排除标准
- •Coronary units, intermediate units, emergency services
- •ICUs that use checklist for the management of the potential donors
- •For potential donors:
- •Age >90 years
- •Metastatic cancer
- •Uncontrolled sepsis
- •Acute hepatitis
- •Acute viral infections
- •Cryptococcal meningoencephalitis and prion diseases
- •Active tuberculosis treated less than 2 months
- •Colonization of the donor by bacteria without any option of antibiotic treatment
- •History of breast tumor, melanoma, soft tissue sarcoma or hematologic neoplasia, WHO Group 3 primary tumors
结局指标
主要结局
Losses of potential donors due to cardiac arrest
时间窗: This event will be evaluated from the date of study subject enrollment until the date of organ recovery or end of brain death protocol (for cases of family refusal or contraindications to organ recovery) assessed up to 14 days
Proportion of losses of potential donors due to cardiac arrest
次要结局
- Organ recovery per effective donor(This event will be evaluated from the date of study subject enrollment until the date of organ recovery assessed up to 14 days)
- Effective organ donor(This event will be evaluated from the date of study subject enrollment until the date of organ recovery or end of brain death protocol (for cases of family refusal or contraindications to organ recovery) assessed up to 14 days)