Traumatic Brain InjuryNCT04361578
Magnetic Resonance Elastography in Patients With Acute Closed Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Xiangya Hospital of Central South University.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Magnetic resonance elastography
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prediction of Short-term Outcome in Patients With Acute Closed Traumatic Brain Injury Using Magnetic Resonance Elastography
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
- Being tested
- Magnetic resonance elastography
- Keywords
- traumatic brain injury, magnetic resonance elastography, brain compliance
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance elastographyDiagnostic test
All patients enrolled will receive magnetic resonance elastography of the brain.
| Study group | Role | What they receive |
|---|---|---|
| Patients | All patients enrolled in the study will be in this group. Receives: Diagnostic Test: Magnetic resonance elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 days after injury
Secondary outcomes (2)
14-day mortality
All-cause mortality within 14 days from injury.
Measured: 14 days after injury
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.
Measured: 14 days after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SWLJF, Xiangya Hospital of Central South University
- Investigators
- Jinfang Liu, M.D., Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361578
- Sponsor's protocol ID
- TBI_MRE
- Status last verified
- Jul 2020
- First submitted
- 22 Apr 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Short-term Outcome in Patients With Acute Closed Traumatic Brain Injury Using Magnetic Resonance Elastography
- ClinicalTrials.gov ID
- NCT04361578
- Acronym / sponsor ID
- TBI_MRE
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, magnetic resonance elastography, brain compliance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Magnetic resonance elastographyAll patients enrolled in the study will be in this group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance elastographyAll patients enrolled will receive magnetic resonance elastography of the brain. | Diagnostic test | Patients |
Primary outcome
14-day ΔGCS
Time frame: 14 days after injury
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).
2 secondary outcomes
14-day mortality
Time frame: 14 days after injury
14-day emergent surgery
Time frame: 14 days after injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinfang Liu, M.D. principal investigator
Xiangya Hospital of Central South University
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziyuan Liu, M.D. (86-151-1137-3960, ethmery@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14-day ΔGCS (time frame: 14 days after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.