Magnetic Resonance Elastography in Patients With Acute Closed Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04361578
• Other study ID #: TBI_MRE
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: July 2020
• Source: Xiangya Hospital of Central South University
• Contact: Ziyuan Liu, M.D.
• Phone: 86-151-1137-3960
• Email: ethmery[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 43
• Est. completion date: August 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• Magnetic resonance elastography
All patients enrolled will receive magnetic resonance elastography of the brain.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	14-day ?GCS	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	14-day mortality	All-cause mortality within 14 days from injury.	14 days after injury
Secondary	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