Magnetic Resonance Elastography in Patients With Acute Closed Traumatic Brain Injury

NCT04361578 | Unknown

• 1 other identifier: TBI_MRE
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; magnetic resonance elastography; brain compliance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 14-day mortality

  14 days after injury

• 14-day emergent surgery

  14 days after injury

Study Arms (1)

Patients

All patients enrolled in the study will be in this group.

Diagnostic Test: Magnetic resonance elastography

Interventions

Magnetic resonance elastography DIAGNOSTIC_TEST

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

Patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jinfang Liu, M.D.

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziyuan Liu, M.D.

CONTACT

86-151-1137-3960; ethmery@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, department of Neurotrauma

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: September 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: August 31, 2021
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share