Magnetic Resonance Elastography in Patients With Acute Closed Traumatic Brain Injury

NCT ID: NCT04361578

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-08-31

Brief Summary

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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

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Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

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Magnetic resonance elastography

Intervention Type DIAGNOSTIC_TEST

All patients enrolled will receive magnetic resonance elastography of the brain.

Interventions

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Magnetic resonance elastography

All patients enrolled will receive magnetic resonance elastography of the brain.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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SWLJF

Director, department of Neurotrauma

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jinfang Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital of Central South University

Central Contacts

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Ziyuan Liu, M.D.

Role: CONTACT

86-151-1137-3960

Other Identifiers

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TBI_MRE

Identifier Type: -

Identifier Source: org_study_id

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