Magnetic Resonance Elastography in Patients With Acute Closed Traumatic Brain Injury

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

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.

Study Overview

• Status: Unknown
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Diagnostic test: Magnetic resonance elastography

• Study Type: Observational
• Enrollment (Anticipated): 43

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute closed traumatic brain injury within 7 days will be enrolled in the study. Patients are conservatively managed (didn't receive surgery yet) according to the judgement of neurosurgeons.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; All patients enrolled in the study will be in this group.	Diagnostic test: Magnetic resonance elastography; All patients enrolled will receive magnetic resonance elastography of the brain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
14-day ΔGCS	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).	14 days after injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
14-day mortality	All-cause mortality within 14 days from injury.	14 days after injury
14-day emergent surgery	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.	14 days after injury

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Investigators: Principal Investigator: Jinfang Liu, M.D., Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: traumatic brain injury; magnetic resonance elastography; brain compliance
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: TBI_MRE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No