Paramedical Evaluation of a Standardize Procedure of Selection of Serious Brain-injured Patients in Therapeutic Abstention to a Brain Death State in the First 48h
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 6
- 主要终点
- Study of the evolution to brain death state within 48 hours of seriously brain-injured patients selected by a standardized procedure and hospitalised in intensive care unit.
研究概览
简要总结
The purpose of this study is to make a paramedical evaluation of a selection procedure of serious brain-injured patient in therapeutic abstention to a brain death state within 48 hours.
详细描述
In 2016 in France, 5891 organs have been transplanted. All the transplant's sources are developed (brain death, Maastricht III, living organ donor).
However, the French Transplant's plan 2017-2021 require always more transplant, the aim is to reach 7800 transplants in 4 years.
To increase the number of transplants, one of the strategies is to actively identify the donors in brain death state and the donors with wider criteria. It's mainly serious brain-injured patients.
The procedure of early announcement of organ donation consists in beginning or pursues intensive care on serious brain-injured patient, for whom a decision of abstention of therapeutic active was decided. The only purpose of the medical care is to notice the brain death state that lead to donation.
In 2010, an expert group of the "Société de reanimation de langue Française" established guidelines to manage organ's donation in serious brain-injured patient after a stroke. The interest, to admit these serious brain-injured patients in intensive care unit, is to increase the number of donors in state of brain death and so the number of transplants.
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
- •Male or Female over 18 years-old
- •Patient with serious brain damages
- •Medical decision of withdrawing life sustaining treatment
- •Signed and dated informed consent by trusted person, or family
- •Patient covered by social security regimen
- •Patient eligible for organ donation according to organ donation hospital co-ordination
- •Glasgow Coma Scale (GCS) :
- •Seriously brain-injured patient without confounding factors, head trauma, brain anoxia or ischemic stroke : GCS<5 and loss of bilateral corneal reflex or GCS<5 and loss of three brain stem reflexes
- •Seriously brain-injured patient with confounding factors and without head trauma, brain anoxia or ischemic stroke : at least one of the following scanographic sign of gravity : deletion of subarachnoid cisterns, more than 15 mm deviation of the median line, hematoma volume > 65 cm3 or hydrocephalus due to intra-ventricular bleeding with V3 or V4 flood, and, if documented, a GCS<
- •Patient with head trauma, brain anoxia or ischemic stroke, reliable clinical examination required (no confounding factor) : GCS<5 and loss of bilateral corneal reflex or GCS<5 and loss of three brain stem reflexes
排除标准
- •No trusted person or family present
- •Seriously brain-injured patient because of head trauma, brain anoxia or ischemic stroke with confounding factors
- •Absolute contraindication to organ donation known at the moment of inclusion (HIV, rabies, active cancer, active tuberculosis, Creutzfeldt-Jakob disease)
结局指标
主要结局
Study of the evolution to brain death state within 48 hours of seriously brain-injured patients selected by a standardized procedure and hospitalised in intensive care unit.
时间窗: 48 hours after validation of eligibility
Rate of patients evolving to brain death state during the first 48 hours following the examination which validates patient's eligibility
次要结局
- Number and type of organ harvested by patient.(48 hours after validation of eligibility)
- Number of patient enrolled by type of service.(48 hours after validation of eligibility)
- Evaluation of the rate of patients with organ removal in enrolled patients.(48 hours after validation of eligibility)
- Number of transplants performed.(10 days)
- Non harvested organs which have been suggested for transplant(10 days)
- Number of refusal causes in the population(48 hours after validation of eligibility)
- Evaluation of the delay between eligibility validation and the passage in brain death state.(48 hours after validation of eligibility)
- Number of patients who performed Maastricht 3 organ donation among patients who didn't evolve to brain death state(10 days)
- Evaluation of call rate to transplant coordination that don't result in a procedure of anticipated announcement(48 hours after validation of eligibility)
- Evaluation of close family refusal rate for pursuit of care during 48h in intensive care unit(48 hours after validation of eligibility)