Impact of Severe Brain Injury on Neuro-vascular and Endothelial Regulation of Peripheral Microcir… (NCT04597879) | Clinical Trial Compass
UnknownNot Applicable
Impact of Severe Brain Injury on Neuro-vascular and Endothelial Regulation of Peripheral Microcirculation.
France30 participantsStarted 2021-08-01
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
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 8.
* 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) ≥ 16.
* absence of associated severe brain injury, defined by an initial Glasgow score less than or equal to 8.
* affiliation to or beneficiary of a social security scheme
* signed informed consent
Exclusion Criteria:
* 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 measu…