Traumatic Brain InjuryMASTER-TBINCT05867992
Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by RenJi Hospital at 1 site in China.
Trial summary
The goal of this experimental observation study is to figure out differently expressed biomarkers in serum in traumatic brain injury patients, compared with bone fracture patients. The main questions it aims to answer are: 1. Which proteins and metabolites are differently expressed in TBI patients' serum? 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Type of trauma
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the case group are these with brain injury, caused by trauma and are severe (GCS 3-8) and in acute period (within 12 hours). Meanwhile, these patients should not have acute bone fracture or other orthopaedic diseases, to avoid any biological detecting bias to control group. Patients in the control group are these with bone fracture, caused by trauma and in acute period (within 12 hours). Also, these patients should not have acute brain injury or other neurological diseases to avoid the same bias in biological detection.
Who may be able to join
- With cerebral contusion in 24Hrs for case group, or with traumatic bone fracture in 24Hrs for control group.
- The Glasglow Coma Scale ranges in 3-8 for case group.
- Need to have routine laboratory examination of blood sample.
- Patients or agents sign the informed consent.
Who cannot join
- With bone fracture for case group, or with brain injury for control group.
- Have Orthopaedic history for case group, or have Neurological history for control group.
- Death in 24 hours.
- Immunosuppressed state.
- Severe multiple organ dysfunction.
- With infection.
- Pregnant.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 201114
Junfeng Feng, Ph.D., +8613611860825, fengjfmail@163.com
Junfeng Feng, Ph.D.
About this study
Official title: Proteomic and Metabolomic Detection and Analysis of Serum from Patients with Acute Severe Traumatic Brain Injury: a Prospective, Multicentered Study
The goal of this experimental observation study is to figure out differently expressed biomarkers in serum in traumatic brain injury patients, compared with bone fracture patients. The main questions it aims to answer are:
- Which proteins and metabolites are differently expressed in TBI patients' serum?
- Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? Participants will be treated by routine treatments, and their serum samples will be collected in the emergency room.
Read the detailed description
This experimental observation study is designed to find out some new characteristics in acute severe traumatic brain injury. To filter the stress response in blood, patients with traumatic fracture are chosen as the control group.
Blood samples of patients who pass the eligibility criteria will be collected immediately in the emergency room. Then the samples will be preprocessed in the laboratory to get serums. These collected serums will be preserved in -80℃ until completing all sample collection. After completing collection, all samples will be sent to proteomic and metabolomic detection. The bioinformatic data will be analyzed to answer these main questions:
- Which proteins and metabolites are differently expressed in TBI patients' serum? (As a whole characteristic of acute severe TBI)
- Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? (Deeply digging the value of characteristic of acute severe TBI)
- Conditions
- Traumatic Brain Injury
- Being tested
- Type of trauma
- Keywords
- Traumatic brain injury, Biomarker, Multiomic analysis, Diagnosis
- Medical subject headings
- Brain Injuries, Traumatic, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of traumaOther
Patients in case group have the severe traumatic brain injury, while patients in control group have the traumatic bone fracture without brain injury.
| Study group | Role | What they receive |
|---|---|---|
| Case group | This group enrolls patients with acute severe traumatic brain injury. Receives: Other: Type of trauma | |
| Control group | This group enrolls patients with acute traumatic bone fracture but without traumatic brain injury. Receives: Other: Type of trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of differently expressed proteins in patients' serum detected by proteomic
Patients' serum will be collected in the emergency room. After collecting all samples, these samples will be detected through proteomic mass spectrometry. The results of proteomic will be further analyzed and compared with control group to filter potential protein biomarkers in serum of severe TBI patients in acute phase.
Measured: First 12 hours in the emergency room
Number of differently expressed metabolites in patients' serum detected by metabolomic
Patients' serum will be collected in the emergency room. After collecting all samples, these samples will be detected through metabolomic mass spectrometry. The results of metabolomic will be further analyzed and compared with control group to filter potential metabolite biomarkers in serum of severe TBI patients in acute phase.
Measured: First 12 hours in the emergency room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Jun 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 Dec 2025 (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 RenJi HospitalThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junfeng Feng, RenJi Hospital
- Investigators
- Junfeng Feng, Ph.D., Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867992
- Sponsor's protocol ID
- LY2024-006
- Acronym
- MASTER-TBI
- Status last verified
- Jan 2024
- First submitted
- 2 May 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic and Metabolomic Detection and Analysis of Serum from Patients with Acute Severe Traumatic Brain Injury: a Prospective, Multicentered Study
- ClinicalTrials.gov ID
- NCT05867992
- Acronym / sponsor ID
- MASTER-TBI / LY2024-006
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, Biomarker, Multiomic analysis, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 May 2023 (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.
The goal of this experimental observation study is to figure out differently expressed biomarkers in serum in traumatic brain injury patients, compared with bone fracture patients. The main questions it aims to answer are:
- Which proteins and metabolites are differently expressed in TBI patients' serum?
- Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? Participants will be treated by routine treatments, and their serum samples will be collected in the emergency room.
Detailed description
This experimental observation study is designed to find out some new characteristics in acute severe traumatic brain injury. To filter the stress response in blood, patients with traumatic fracture are chosen as the control group.
Blood samples of patients who pass the eligibility criteria will be collected immediately in the emergency room. Then the samples will be preprocessed in the laboratory to get serums. These collected serums will be preserved in -80℃ until completing all sample collection. After completing collection, all samples will be sent to proteomic and metabolomic detection. The bioinformatic data will be analyzed to answer these main questions:
- Which proteins and metabolites are differently expressed in TBI patients' serum? (As a whole characteristic of acute severe TBI)
- Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? (Deeply digging the value of characteristic of acute severe TBI)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: Type of traumaThis group enrolls patients with acute severe traumatic brain injury. |
| Control group | – | Other: Type of traumaThis group enrolls patients with acute traumatic bone fracture but without traumatic brain injury. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the case group are these with brain injury, caused by trauma and are severe (GCS 3-8) and in acute period (within 12 hours). Meanwhile, these patients should not have acute bone fracture or other orthopaedic diseases, to avoid any biological detecting bias to control group. Patients in the control group are these with bone fracture, caused by trauma and in acute period (within 12 hours). Also, these patients should not have acute brain injury or other neurological diseases to avoid the same bias in biological detection.
Key inclusion criteria (4 listed)
- With cerebral contusion in 24Hrs for case group, or with traumatic bone fracture in 24Hrs for control group.
- The Glasglow Coma Scale ranges in 3-8 for case group.
- Need to have routine laboratory examination of blood sample.
- Patients or agents sign the informed consent.
Key exclusion criteria (7 listed)
- With bone fracture for case group, or with brain injury for control group.
- Have Orthopaedic history for case group, or have Neurological history for control group.
- Death in 24 hours.
- Immunosuppressed state.
- Severe multiple organ dysfunction.
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 |
|---|---|---|
| Type of traumaPatients in case group have the severe traumatic brain injury, while patients in control group have the traumatic bone fracture without brain injury. | Other | Case group, Control group |
Primary outcome
Number of differently expressed proteins in patients' serum detected by proteomic
Time frame: First 12 hours in the emergency room
Patients' serum will be collected in the emergency room. After collecting all samples, these samples will be detected through proteomic mass spectrometry. The results of proteomic will be further analyzed and compared with control group to filter potential protein biomarkers in serum of severe TBI patients in acute phase.
Number of differently expressed metabolites in patients' serum detected by metabolomic
Time frame: First 12 hours in the emergency room
Patients' serum will be collected in the emergency room. After collecting all samples, these samples will be detected through metabolomic mass spectrometry. The results of metabolomic will be further analyzed and compared with control group to filter potential metabolite biomarkers in serum of severe TBI patients in acute phase.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Junfeng Feng, Ph.D. principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by RenJi Hospital at 1 site in China.
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 7 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 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Zhenghui He, M.D. (+8613585916217, hezhenghui8@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of differently expressed proteins in patients' serum detected by proteomic (time frame: First 12 hours in the emergency room). The study lists 2 primary outcomes in all. 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 5 Sep 2024.