Condition or disease | Intervention/treatment |
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Traumatic Brain Injury | Diagnostic Test: diagnostic of specific biomarkers |
Study Type : | Observational |
Estimated Enrollment : | 450 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | The Research for New Clinical Diagnostic Strategy of Specific Biomarkers for Traumatic Brain Injury |
Actual Study Start Date : | June 4, 2020 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2022 |
Group/Cohort | Intervention/treatment |
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Normal group
normal population
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Brain injury group
patients with traumatic brain injury within 24 hours
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Diagnostic Test: diagnostic of specific biomarkers
Protein and metabolic product differences will be detected from blood or lesion samples of normal population, patients with traumatic brain injury and/or non-brain injury using mass spectrometry proteomics and metabolomics analysis platform. Diagnostic markers of potential traumatic brain injury will be found, and their differential diagnostic values were discussed.
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Non-brain injury group
Non-brain injury group refers to patients with limb injury or systemic injury except brain injury.
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Diagnostic Test: diagnostic of specific biomarkers
Protein and metabolic product differences will be detected from blood or lesion samples of normal population, patients with traumatic brain injury and/or non-brain injury using mass spectrometry proteomics and metabolomics analysis platform. Diagnostic markers of potential traumatic brain injury will be found, and their differential diagnostic values were discussed.
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Fei Niu | +86-18701075929 | nf520621@163.com |
China, Anhui | |
The First Affiliated Hospital of Anhui Medical University | Recruiting |
Hefei, Anhui, China | |
Contact: Xiang Mao |
Tracking Information | |||||
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First Submitted Date | June 3, 2019 | ||||
First Posted Date | June 6, 2019 | ||||
Last Update Posted Date | June 11, 2020 | ||||
Actual Study Start Date | June 4, 2020 | ||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | The Research for New Clinical Diagnostic Strategy of Specific Biomarkers for Traumatic Brain Injury | ||||
Official Title | The Research for New Clinical Diagnostic Strategy of Specific Biomarkers for Traumatic Brain Injury | ||||
Brief Summary | Traumatic brain injury (TBI) is the most common type of nerve injury and it severely endangers the public health. It is necessary to accurately measure the early neurological function of brain injury for monitoring its prognosis and therapeutic interventions. Glasgow Coma Score (GCS) and Computed Tomography (CT) are often used to diagnose the severity of TBI. However, GCS has its drawbacks in the observation of prognosis, because it is interfered by analgesics, sedatives and relaxants in the evaluation of neurological function. CT may miss the diagnosis of diffuse axonal injury (DAI) and the monitoring of intracranial pressure (ICP). Secondary injuries after TBI, such as oxidative stress, inflammatory damage, and abnormal metabolism, can destroy cerebral blood vessels and structures, which also affect the diagnosis of injury. Therefore, there is an urgent need for new methods to quickly identify which patients are likely to suffer brain injury or even cause persistent disability. Detection of brain injury biomarkers based on blood and brain tissue has long been used to assess the severity of TBI, but no biomarkers have been found for early diagnosis of mTBI and prognosis of different degrees of brain injury. Protein and metabolic product differences were detected from blood or the lesion samples of normal population, patients with traumatic brain injury and/or non-brain injury using mass spectrometry proteomics and metabolomics analysis platform, and diagnostic markers of potential traumatic brain injury were found, and their differential and diagnostic values were discussed. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | normal population, patients with brain injury within 24h combined with or without systemtic injuries. | ||||
Condition | Traumatic Brain Injury | ||||
Intervention | Diagnostic Test: diagnostic of specific biomarkers
Protein and metabolic product differences will be detected from blood or lesion samples of normal population, patients with traumatic brain injury and/or non-brain injury using mass spectrometry proteomics and metabolomics analysis platform. Diagnostic markers of potential traumatic brain injury will be found, and their differential diagnostic values were discussed.
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
450 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 31, 2022 | ||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
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Listed Location Countries | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03976492 | ||||
Other Study ID Numbers | BTHospital KY2019-012-04 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Baiyun Liu, Beijing Tiantan Hospital | ||||
Study Sponsor | Baiyun Liu | ||||
Collaborators | The First Affiliated Hospital of Anhui Medical University | ||||
Investigators | Not Provided | ||||
PRS Account | Beijing Tiantan Hospital | ||||
Verification Date | June 2020 |