The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury
NCT ID: NCT02639923
Last Updated: 2022-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
155 participants
OBSERVATIONAL
2016-01-31
2021-12-01
Brief Summary
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S100B serum levels will be measured in both groups. The usual risk factors for the occurrence of an intracranial hematoma (diagnostic algorithm) will be recorded. Additionally, a group of healthy individuals will serve as a control group.
Detailed Description
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The investigators plan to include 60 patients with minor head injury (MHI) admitted to our hospital within one year (1-2 each week):
1\. 30 patients in the CCT pos. group, i.e. patients with an intracranial hematoma on emergency CT scan. 2. 30 patients with MHI in the CCT neg. group, i.e. patients without an intracranial traumatic lesion on emergency CT-scan. 3. Additionally, 30 healthy volunteers will be included.
Patients with multiple injuries i.e. polytraumatized patients, patients with severe traumatic brain injury, patients with open fractures and fractures of the long bones, as well as pregnant patients and patients \<18 years, are excluded from the study.
Patients with a GCS (Glascow Coma Scale) of 13-15 are usually able to consent to be enrolled in the clinical trial. Generally, their reasoning and judgment is not impaired.
The objective of the study is to compare 3 groups on the microRNA serum levels.
The investigators plan to draw blood from a peripheral catheter in the patients of groups 1 and 2 (within 6 hours) after arrival at the hospital together with the routine laboratory investigations. Additionally, blood will be obtained from healthy volunteers (group 3).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Minor head injury CCT pos. group
Tbi patients with acute lesion on early cranial computed tomography. Patients consent to have 7ml peripheral blood to be drawn.
Drawing of 7ml peripheral blood
puncture peripheral vein
Minor head injury CCT neg. group
Tbi patients without acute lesion on early cranial computed tomography. Patients consent to have 7ml peripheral blood to be drawn.
Drawing of 7ml peripheral blood
puncture peripheral vein
Control Group (healthy volunteers)
Volunteers without history, signs or symptoms of acute traumatic injuries. Volunteers consent to have 7ml peripheral blood to be drawn.
Drawing of 7ml peripheral blood
puncture peripheral vein
Interventions
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Drawing of 7ml peripheral blood
puncture peripheral vein
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Medical Scientific Fund of the Mayor of Vienna
OTHER
Harald Wolf, MD
OTHER
Responsible Party
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Harald Wolf, MD
Oberarzt Dr. Harald Wolf
Principal Investigators
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Harald Wolf, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department for Trauma Surgery, Medical University of Vienna
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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References
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Balakathiresan N, Bhomia M, Chandran R, Chavko M, McCarron RM, Maheshwari RK. MicroRNA let-7i is a promising serum biomarker for blast-induced traumatic brain injury. J Neurotrauma. 2012 May 1;29(7):1379-87. doi: 10.1089/neu.2011.2146. Epub 2012 Apr 13.
Sharma A, Chandran R, Barry ES, Bhomia M, Hutchison MA, Balakathiresan NS, Grunberg NE, Maheshwari RK. Identification of serum microRNA signatures for diagnosis of mild traumatic brain injury in a closed head injury model. PLoS One. 2014 Nov 7;9(11):e112019. doi: 10.1371/journal.pone.0112019. eCollection 2014.
Redell JB, Moore AN, Ward NH 3rd, Hergenroeder GW, Dash PK. Human traumatic brain injury alters plasma microRNA levels. J Neurotrauma. 2010 Dec;27(12):2147-56. doi: 10.1089/neu.2010.1481. Epub 2010 Nov 23.
Redell JB, Zhao J, Dash PK. Altered expression of miRNA-21 and its targets in the hippocampus after traumatic brain injury. J Neurosci Res. 2011 Feb;89(2):212-21. doi: 10.1002/jnr.22539. Epub 2010 Dec 8.
Other Identifiers
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Wolf-7
Identifier Type: -
Identifier Source: org_study_id