Brain Injuries, TraumaticmRNANCT02639923
The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury
An observational study of Brain Injuries, Traumatic, run by Harald Wolf, MD at 1 site in Austria.
Trial summary
The aim of this study is to investigate the early serum measurement (<6h after injury) of mRNA miR Let-7i, miR-16 and miR-92 in patients with MHI and intracranial traumatic lesions (CCT pos.) as compared to those in patients with MHI without intracranial traumatic lesions (CCT neg.). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Drawing of 7ml peripheral blood
- Type of treatment
- Surgery or procedure
- How many people
- 155 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2016to 1 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We plan to include 60 patients with minor head injury (MHI) GCS 13-15 admitted to our hospital within one year (1-2 each week).
Who may be able to join
- TBI with GCS 13-15
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury A Pilot Study
The aim of this study is to investigate the early serum measurement (<6h after injury) of mRNA miR Let-7i, miR-16 and miR-92 in patients with MHI and intracranial traumatic lesions (CCT pos.) as compared to those in patients with MHI without intracranial traumatic lesions (CCT neg.).
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.
During the study, technical and scientific capabilities and options increased and two further mRNA´S (miR-124-3p and miR-9-5p) will be investigated, too.
Read the detailed description
Patients and Methods
The investigators plan to include 60 patients with minor head injury (MHI) admitted to our hospital within one year (1-2 each week):
- 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
- Brain Injuries, Traumatic
- Being tested
- Drawing of 7ml peripheral blood
- Keywords
- TBI, microRNA, S-100B
- 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.
Drawing of 7ml peripheral bloodProcedure or surgery
Also called 7ml serum
puncture peripheral vein
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Drawing of 7ml peripheral blood | |
| 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. Receives: Procedure: Drawing of 7ml peripheral blood | |
| Control Group (healthy volunteers) | Volunteers without history, signs or symptoms of acute traumatic injuries. Volunteers consent to have 7ml peripheral blood to be drawn. Receives: Procedure: Drawing of 7ml peripheral blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothesis: Significant elevation or decrease of the mRNAs miR Let-7i, miR-16 and miR-92 among the study groups
non of the measured biomarker shows a significant difference between the 3 study groups
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- 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
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harald Wolf, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Scientific Fund of the Mayor of Vienna
- Responsible party
- Sponsor-investigator, Harald Wolf, MD, Medical University of Vienna
- Investigators
- Harald Wolf, M.D., Principal investigator, Department for Trauma Surgery, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639923
- Sponsor's protocol ID
- Wolf-7
- Acronym
- mRNA
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2015
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22352906Sharma 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.
PubMed 25379886Redell 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.
PubMed 20883153Redell 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.
PubMed 21162128
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury A Pilot Study
- ClinicalTrials.gov ID
- NCT02639923
- Acronym / sponsor ID
- mRNA / Wolf-7
- Conditions
- Brain Injuries, Traumatic
- Keywords
- TBI, microRNA, S-100B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Harald Wolf, MDUniversity, hospital or other
- Collaborators
- Medical Scientific Fund of the Mayor of Vienna
- Study start
- Jan 2016
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 28 Dec 2015 (estimated)
- 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 aim of this study is to investigate the early serum measurement (<6h after injury) of mRNA miR Let-7i, miR-16 and miR-92 in patients with MHI and intracranial traumatic lesions (CCT pos.) as compared to those in patients with MHI without intracranial traumatic lesions (CCT neg.).
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.
During the study, technical and scientific capabilities and options increased and two further mRNA´S (miR-124-3p and miR-9-5p) will be investigated, too.
Detailed description
Patients and Methods
The investigators plan to include 60 patients with minor head injury (MHI) admitted to our hospital within one year (1-2 each week):
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Minor head injury CCT pos. group | – | Procedure: Drawing of 7ml peripheral bloodTbi patients with acute lesion on early cranial computed tomography. Patients consent to have 7ml peripheral blood to be drawn. |
| Minor head injury CCT neg. group | – | Procedure: Drawing of 7ml peripheral bloodTbi patients without acute lesion on early cranial computed tomography. Patients consent to have 7ml peripheral blood to be drawn. |
| Control Group (healthy volunteers) | – | Procedure: Drawing of 7ml peripheral bloodVolunteers without history, signs or symptoms of acute traumatic injuries. Volunteers consent to have 7ml peripheral blood to be drawn. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to include 60 patients with minor head injury (MHI) GCS 13-15 admitted to our hospital within one year (1-2 each week).
Key inclusion criteria (1 listed)
- TBI with GCS 13-15
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Drawing of 7ml peripheral bloodAlso: 7ml serumpuncture peripheral vein | Procedure or surgery | Control Group (healthy volunteers), Minor head injury CCT neg. group, Minor head injury CCT pos. group |
Primary outcome
Hypothesis: Significant elevation or decrease of the mRNAs miR Let-7i, miR-16 and miR-92 among the study groups
Time frame: 6 hours
non of the measured biomarker shows a significant difference between the 3 study groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 22352906Balakathiresan 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.
- Results publication: PubMed 25379886Sharma 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.
- Results publication: PubMed 20883153Redell 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.
- Results publication: PubMed 21162128Redell 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.
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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.
Harald Wolf, M.D. principal investigator
Department for Trauma Surgery, Medical University of Vienna
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 Brain Injuries, Traumatic, run by Harald Wolf, MD at 1 site in Austria.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Apr 2026. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypothesis: Significant elevation or decrease of the mRNAs miR Let-7i, miR-16 and miR-92 among the study groups (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02639923, which also lists 4 linked publications.
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 22 Apr 2026.