Study of the Impact of Severe Brain Injury on the Neuro-vascular and Endothelial Regulation of Peripheral Microcirculation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Post-occlusive hyperaemia
研究概览
简要总结
Severe brain injury (SBI) is one of the world's leading causes of death and disability in young adults, but its peripheral vascular consequences in humans are poorly understood.
This prospective, monocentric, pathophysiological study aims to investigate differences in vasoreactivity in the anterior aspect of the contralateral forearm at the most injured cerebral hemisphere between patients with severe head trauma and patients with severe trauma without associated brain injury matched on sex and age (+/- 5 years).
详细描述
Severe brain injury (SBI) is one of the world's leading causes of death and disability in young adults.
Its impact on cerebral vascularization is well known. At the systemic level, it induces transient dysfunctions that can develop into severe failures, even in cases of isolated SBI. Studies on a mouse model of SBI show alterations in peripheral vascular reactivity that persist over time and are linked to endothelial dysfunction, the mechanism of which is a decoupling of endothelial NO synthase in a context of systemic inflammation. However, no data are available regarding the peripheral vascular consequences of SBI in humans.
The main objective of this prospective, monocentric, pathophysiological study is to determine whether the postocclusive hyperaemic response at the anterior surface of the contralateral forearm to the most injured cerebral hemisphere differs between patients with severe brain injury and patients with severe trauma without associated head injury matched on sex and age (+/- 5 years), by studying the amplitude of post-occlusive hyperaemia (maximum amplitude expressed as percentage of vasodilatation and area under the curve : AUC) as a function of the group.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers :
- •Men and women, over 18 years of age
- •Affiliation to a social security scheme
- •Signed Consent
- •Patients with Severe Brain Injury :
- •Male and female, over 18 years of age
- •Isolated severe brain injury, defined by an initial Glasgow score less than or equal to
- •Affiliation to a social security scheme
- •Signed informed consent
- •Severe traumatized patients without associated severe brain injury:
- •men and women, over 18 years of age
- •severe trauma, defined by an Injury Severity Score (ISS) ≥
- •absence of associated severe brain injury, defined by an initial Glasgow score less than or equal to
- •affiliation to or beneficiary of a social security scheme
- •signed informed consent
排除标准
- •Hypersensitivity to lidocaine and/or prilocaine or to amide type local anesthetics or to any of the excipients of the cream.
- •History of axillary lymph node dissection, trauma or axillary surgery
- •Prohibited treatments and procedures :
- •In patients with head trauma: ongoing treatment with systemic vasodilators (calcium channel blocker, milrinone).
- •In healthy volunteers: no treatment will be authorized other than paracetamol, hormone supplementation (contraceptive pill, hormone therapy, thyroid hormones).
- •Pregnant, parturient or breastfeeding women
- •Subject in a period of exclusion from another study,
- •Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure,
- •Subject having exceeded the annual compensation threshold for testing
- •Subject cannot be contacted in case of emergency
结局指标
主要结局
Post-occlusive hyperaemia
时间窗: 0-60 days
Maximum amplitude expressed as percentage of vasodilation and area under the curve: AUC
次要结局
- Current-Induced Hyperaemia(0-60 days)
- Current-Induced Hyperaemia with local anesthesia(0-60 days)
- Local thermal hyperaemia(0-60 days)
- Local thermal hyperaemia with local anesthesia(0-60 days)
- Post-occlusive hyperaemia with local anesthesia(0-60 days)
- Flow amplitude after local cooling(0-60 days)
- Transient venous post-compression hyperaemia(0-60 days)
- Study of vasoreactivity in patients with severe brain injury(0-60 days)
- Study of vasoreactivity in healthy subjects(Study visit)