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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04361578
Enrollment
43
Registered
2020-04-24
Start date
2020-09-01
Completion date
2021-08-31
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury, magnetic resonance elastography, brain compliance

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.

Interventions

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

Sponsors

Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
14-day ΔGCS14 days after injuryChange 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

MeasureTime frameDescription
14-day mortality14 days after injuryAll-cause mortality within 14 days from injury.
14-day emergent surgery14 days after injuryEmergent 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.

Contacts

Primary ContactZiyuan Liu, M.D.
ethmery@yeah.net86-151-1137-3960

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026