NCT01512524已完成不适用
Long Term Follow-up of Moderate and Severe Traumatic Bain Injury and Assessment of Involvement of Hormonal Deficiency in the Quality of Life
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Evolution of the SF-36(Short-Form health survey)score up to 18 months post-trauma
研究概览
简要总结
The primary objective is to assess the long-term impact of hormonal deficiency on Quality of Life (QoL) in a large group of moderate and severe Traumatic Brain Injury (TBI) patients.
详细描述
Severe Traumatic Brain Injury, when not leading to mortality, is a major cause of morbidity in early adulthood.
Recent studies have demonstrated a previously unappreciated association between Severe Traumatic Brain Injury and endocrine dysfunction.
The current trial aims at evaluating the quality of life 18 months post-trauma and associating this outcome to growth hormone levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must be between the ages of 18-65
- •Documented moderate to severe Traumatic Brain Injury (TBI) at less than 4 months post injury.
- •Glasgow Coma Scale (GCS) equal to or greater than 12
- •Patients volunteer to participate in the study, with a written informed consent signed
- •BMI between 17 kg/m2 - 30kg/m2
- •Affiliation to a national health insurance program
排除标准
- •Glasgow Coma Scale (GCS) ≥13
- •History of TBI ≥4 months
- •Anterior hypopituitarism documented
- •History of radiotherapy
- •Liver dysfunction: total bilirubin <20µmol/l and/or factor V<60%)
- •Renal dysfunction: creatinine clearance < 30 ml/mn (Cockcroft & Gault)
- •Anyone who is currently taking or who has taken corticotherapy in the last 4 weeks before TBI
- •Pregnancy
- •Contraindications to MRI:
- •Patients who have a heart pacemaker
- •Patients who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain
- •Patients with severe claustrophobia
结局指标
主要结局
Evolution of the SF-36(Short-Form health survey)score up to 18 months post-trauma
时间窗: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.
次要结局
- QOLIBRI (Quality of Life after Brain Injury) measure #1(assessed at 4 months (M4), 12 months (M12)and 18 months (M18) after brain injury.)
- Questions on Life Satisfaction-Hypopituitarism (QLS-H) measure #2(Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.)
- Tests of Attentional, mnesic and executive performances #3(assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.)
- Functional outcomes (#4):The Glasgow Outcome Scale (GOS)-Score(assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.)
- Functional outcome #5 :the Functional Independence Measure (FIM)(assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.)
研究者
研究点 (2)
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