Magnetic Resonance Elastography in Patients With Acute Closed Traumatic Brain Injury

• Conditions: Traumatic Brain Injury
• Interventions: Diagnostic Test: Magnetic resonance elastography

• Registration Number: NCT04361578
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-02
• Last Update Posted: 2020-07-07
• Study Start: 2020-09-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Magnetic resonance elastography	All patients enrolled in the study will be in this group.

Primary Outcome Measures

Name	Time	Method
14-day ΔGCS	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).

Secondary Outcome Measures

Name	Time	Method
14-day mortality	14 days after injury	All-cause mortality within 14 days from injury.
14-day emergent surgery	14 days after injury	Emergent surgery due to intracranial pathology within 14 days from injury. The decision of emergent surgery (evacuation of newly emerged hematoma, decompressive craniectomy due to refractory intracranial hypertension, etc) is determined by attending neurosurgeon.