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临床试验/NCT04361578
NCT04361578Unknown不适用

Prediction of Short-term Outcome in Patients With Acute Closed Traumatic Brain Injury Using Magnetic Resonance Elastography

Xiangya Hospital of Central South University0 个研究点目标入组 43 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
43
主要终点
14-day ΔGCS

研究概览

简要总结

Traumatic brain injury (TBI) is a major public health issue, and intracranial hypertension in the acute phase remains a critical scientific issue. Many patients with acute closed TBI received conservative, non-surgical treatments at first, while 5%~19% of which develops intractable intracranial hypertension that requires emergent surgery. Therefore, it is of great clinical significance to identify patients who are at high risk of deterioration in the early stage. Previous studies have found that brain compliance is a contributive factor to intracranial pressure, and might serve in the development of intracranial hypertension after TBI. We made assumption that intracranial pressure has a negative relationship with brain compliance providing that the volume of hematoma remains constant. However, few studies have applied magnetic resonance elastography (MRE) in evaluating brain compliance in patients with TBI. Therefore, this study is designed to enroll patients with acute closed traumatic brain injury who are initially treated non-surgically. Magnetic resonance elastography (MRE) sequences are performed to non-invasively assess patients' brain compliances, in the hope of exploring the potential value of MRE biomarkers to predict the short-term outcome in patients with acute closed TBI who are initially receive non-surgical treatments.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-60 years old
  • Acute closed traumatic brain injury within 7 days
  • Not receiving surgical intervention according to the judgement of neurosurgeons
  • Expected tolerance of magnetic resonance imaging (MRI) scan 7 days from injury

排除标准

  • Vital organ failure: congestive heart failure, respiratory failure, renal failure (CKD≥stage 3), severe hepatic dysfunction (Child-Pugh stage B or C)
  • Any central nervous system (CNS) pathology prior to injury: stroke, epilepsy, CNS tumour/infections, dementia or other neurodegenerative diseases
  • CT reveals infratentorial hematoma
  • Contraindications of MRI
  • Currently enrolled in other researches

结局指标

主要结局

14-day ΔGCS

时间窗: 14 days after injury

Change of Glasgow Coma Scale (GCS) 14 days after injury from GCS at admission. The GCS is a indication of patient's conscious status, ranging from 3 (poor) to 15 (good).

次要结局

  • 14-day mortality(14 days after injury)
  • 14-day emergent surgery(14 days after injury)

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

SWLJF

Director, department of Neurotrauma

Xiangya Hospital of Central South University

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