Long Term Effects of Erythropoietin in Patients With Moderate to Severe Traumatic Brain Injury A Follow-up Study of an International Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Mortality and time to mortality at least 2 years from injury
研究概览
简要总结
Traumatic brain injury is catastrophic event that commonly require treatment in an intensive care unit. Management is mainly supportive aiming at avoiding hypoxia, hypotension, hypoglycaemia and increased intracerebral pressure. Thus far efforts to find a specific pharmacologic therapies have been disappointing. Recently it was demonstrated that recombinant erythropoietin has been found to decrease mortality at six months from injury but without significantly improving functional neurological outcome (GOSe). Whether this survival benefit of EPO is sustained beyond 6 months is unknown.
In the current study survival data will be collected centrally and patients alive or person responsible will be invited to participate in an evaluation of neurological function and quality of life. Factors associated with time to death as well as factors associated with long term quality of life will be determined with statistical methods.
详细描述
Aim: In this post hoc study of a RCT the primary aim is to determine the effect of EPO compared to placebo in improving outcome, including survival, neurological function and quality of life two years after the conclusion of the EPO-TBI study (two to seven years after moderate or severe TBI occurring in individual patients).
Design: A long term follow-up study of a prospective, multi-centre, double blind, phase III, randomised controlled trial.
Methods: Survival status at the time when this follow-up trial is executed will obtained in all patients. Time from injury will vary between 2 to 7 years depending on when the patient was enrolled. This information will obtained from hospital notes, national register offices and/or national statistical bureaus. Since the trial was an international RCT, strategies may vary and will take into account local circumstances. Local plans will be developed by the local principal investigators and approved by the management committee.
Data includes
- Survival status at long term follow up (alive/dead)
- Time from injury to assessment (days)
- If the patients is deceased, time of death and time from injury in days
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the EPO-TBI study without withdrawal of informed consent.
- •Exclusion criteria:
- •Failure to to consent for the conduction of the follow-up assessment.
排除标准
- 未提供
研究组 & 干预措施
Erythropoietin
Patients were treated with EPO during the EPO-TBI study in 2010-2014.
干预措施: erythropoietin (Drug)
Placebo
Patients were treated with placebo during the EPO-TBI study in 2010-2014.
干预措施: Placebos (Drug)
结局指标
主要结局
Mortality and time to mortality at least 2 years from injury
时间窗: 2-7 years from injury
Survival status with time to death in those deceased
次要结局
- EQ-5D(2-7 years from injury)
- Glasgow outcome scale extended(2-7 years from injury)
- SF-12(2-7 years from injury)
研究者
David James Cooper
Director
Australian and New Zealand Intensive Care Research Centre