Clinical trial NCT04361578: Magnetic Resonance Elastography in Patients With Acute Closed Traumatic Brain Injury
Official title: Prediction of Short-term Outcome in Patients With Acute Closed Traumatic Brain Injury Using Magnetic Resonance Elastography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
magnetic resonance elastography
brain compliance
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 14-day ΔGCS
timeFrame: 14 days after injury
Secondary outcomes:
measure: 14-day mortality
timeFrame: 14 days after injury
measure: 14-day emergent surgery
timeFrame: 14 days after injury
Other outcomes:
Locations:
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Jinfang Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: