Continuous Hyperosomolar Therapy for Traumatic Brain-injured Patients Study Protocol for a Multicenter Randomized Open-label Trial With Blinded Adjudication of Primary Outcome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 10
- 主要终点
- Score on the Extended Glasgow Outcome Scale (GOS-E) at 6 months
研究概览
简要总结
Traumatic brain injury (TBI) is a major cause of death and severe prolonged disability. Intracranial hypertension (ICH) is a critical risk factor of bad outcomes after TBI. Continuous infusion of hyperosmolar therapy has been proposed for the prevention or the treatment of ICH. Whether an early administration of continuous hyperosmolar therapy improves long term outcomes is uncertain. The aim of the current study is to assess the efficiency and the safety of continuous hyperosmolar therapy in TBI patients.
The COBI trial is the first randomized controlled trial powered to investigate whether continuous hyperosmolar therapy in TBI patients improve long term recovery.
Hypothesis
Patients treated with early continuous hyperosmolar therapy have reduced morbidity and mortality rates compared to those receiving standard care alone after traumatic brain injury.
Research Questions
- Does early continuous hyperosmolar therapy reduce morbidity and mortality rates at 3 and 6 months after TBI assessed by the GOSE questionnaire?
- Does early continuous hyperosmolar therapy prevent intracranial hypertension?
详细描述
Background Traumatic brain injury (TBI) is a major cause of death and severe prolonged disability. Intracranial hypertension (ICH) is a critical risk factor of bad outcomes after TBI.
Continuous infusion of hyperosmolar therapy has been proposed for the prevention or the treatment of ICH. Whether an early administration of continuous hyperosmolar therapy improves long term outcomes is uncertain. The aim of the current study is to assess the efficiency and the safety of continuous hyperosmolar therapy in TBI patients.
Methods The COBI (Continuous hyperosmolar therapy in traumatic brain-injured patients) trial is a multicenter, randomized, controlled, open-label, two-arms study with blinded adjudication of primary outcome. Three hundred and seventy patients hospitalized in Intensive Care Unit with a traumatic brain injury (Glasgow Coma Scale ≤ 12 and abnormal brain CT-scan) are randomized in the first 24 hours following trauma to standard care or continuous hyperosmolar therapy (NaCl 20%) plus standard care. Continuous hyperosmolar therapy is maintained for at least 48 hours in the treatment group and continued for as long as is necessary to prevent intracranial hypertension. The primary outcome is the score on the Extended Glasgow Outcome Scale (GOS-E) at 6 months. The treatment effect is estimated with ordinal logistic regression adjusted for pre-specified prognostic factors and expressed as a common odds ratio.
Discussion The COBI trial is the first randomized controlled trial powered to investigate whether continuous hyperosmolar therapy in TBI patients improve long term recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Masking: Open label , Masked Roles: Subject and Outcomes assessor
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •Moderate to severe traumatic brain injury defined as the association of a Coma Glasgow Scale ≤ 12 together with a traumatic abnormal brain CT-scan
- •Time to inclusion inferior to 24 hours
- •Informed consent (or emergency procedure)
排除标准
- •dependence for daily activity
- •Coma Glasgow Scale of 3 and fixed dilated pupils
- •associated cervical spine injury
- •imminent death and do-not-resuscitate orders
- •pregnancy.
- •Major not legally responsible
- •Oedemato-ascitic decompensation of hepatic cirrhosis
- •State of hydro-sodium retention secondary to heart failure
研究组 & 干预措施
Continuous hyperosmolar therapy
Standard cares plus continuous hyperosmolar therapy (NaCl20%)
干预措施: NaCl20% (Continuous hyperosmolar therapy) (Drug)
结局指标
主要结局
Score on the Extended Glasgow Outcome Scale (GOS-E) at 6 months
时间窗: 6 months
The GOS-E is a scale measuring the neurological recovery after traumatic brain injuries
次要结局
- Blood level of chlore(7 Days)
- Mortality rate in ICU(6 months)
- Blood level of sodium(7 Days)
- Rate of acute kidney injury(28 days)
- Rate of centropontine myelinolysis(28 days)
- brain oxygenation (PtiO2)(5 Days)
- Rate of patients with anterograde amnesia(6 months)
- blood osmolality(7 Days)
- Rate of thrombo-embolic events(28 days)
- Blood level of potassium(5 Days)
- weight(5 Days)
- GOS-E(3 months)
- functional independence measure : ADL (Activities of Daily Living) of Katz(6 months)
- Short Form 36(6 months)
- Intracranial pressure control(7 Days)
- Blood level of pH (Hydrogen Potention)(5 Days)
- blood level of creatinine(5 Days)
- Diuresis(5 Days)
- Ancillary study: questionnaire HADS (Hospital Anxiety and Depression Scale) in patient's relative(6 months)