Clinical Outcomes and Predictors of PITuitary Disorders in Patients With Moderate and Severe Traumatic Brain Injury: the PIT-TBI Prospective Multicenter Pilot Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Enrollment Rate
研究概览
简要总结
Damage to the pituitary gland is a frequently overlooked but potentially important complication of traumatic brain injury (TBI). Disorders of the pituitary gland can cause dysfunction of the thyroid, adrenals, ovaries and testes. These disorders may occur immediately or several months after TBI, may delay recovery and may have a significant negative impact on quality of life. TBI is the leading cause of disability and major permanent functional impairment among adults under 45 years of age. Hormonal deficits may contribute to common symptoms experienced by TBI survivors such as fatigue, poor concentration, depression and low exercise capacity. However, the association between hormonal deficits and disability remains uncertain. The primary objective of this pilot study is to assess the feasibility of a larger study that will evaluate the impact of pituitary disorders on neurological disability and functional recovery. The results of this study will provide key findings in the impact of pituitary disorders following TBI, which is a mandatory step prior testing the effect of hormonal replacement therapy in this population in costly clinical trials. If no relationship between pituitary disorders and disability is observed, the investigators' findings will prevent unnecessary, time-consuming and costly hormonal screening and will discourage potentially harmful hormonal therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Adult (≥ 18 years old)
- •Severe or moderate blunt TBI admitted to the ICU with a Glasgow Coma Scale ≤ 12 following initial resuscitation
排除标准
- •Previously diagnosed or suspected pituitary disorder or disease
- •Pregnant or lactating woman
- •Penetrating TBI
- •Solid malignancy with life expectation <12 months
- •Liver Cirrhosis Child C
- •Chronic Heart Failure (New York Heart Association class IV)
- •End-stage chronic respiratory disease (O2 dependent)
- •End-stage renal disease (chronic dialysis or to be expected)
- •Neurological conditions influencing functional status (e.g. spinal cord injury, neuromuscular disease, dementia, prior TBI or stroke)
- •No fixed address
- •Physician refusal
- •Brain death
- •Unable to return to the study center to attend the follow-up visits
- •Admission to the Intensive Care Unit of the participating center > 24 hours after TBI
结局指标
主要结局
Enrollment Rate
时间窗: 12 months
Number of patients recruited per month per site
Adherence to the Protocol
时间窗: 12 months
Percentage of participants who underwent pituitary function evaluation and outcome measures as detailed in the Assigned Interventions section
次要结局
- Secondary hypogonadism(12 months)
- Growth hormone deficit(12 months)
- Neurological Recovery(12 months)
- Quality of life(12 months)
- Independent functioning(12 months)
- Life satisfaction(12 months)
- Secondary adrenal insufficiency(12 months)
- Depression(12 months)
- Secondary hypothyroidism(12 months)
研究者
François Lauzier
MD MSc FRCPC
CHU de Quebec-Universite Laval