NCT02639923

Brief 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.). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

5.9 years

First QC Date

December 2, 2015

Last Update Submit

April 17, 2026

Conditions

Brain Injuries, Traumatic

Keywords

TBImicroRNAS-100B

Outcome Measures

Primary Outcomes (1)

  • 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

    6 hours

Study Arms (3)

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.

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.

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.

Procedure: Drawing of 7ml peripheral blood

Interventions

Drawing of 7ml peripheral bloodPROCEDURE

puncture peripheral vein

Also known as: 7ml serum
Control Group (healthy volunteers)Minor head injury CCT neg. groupMinor head injury CCT pos. group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

  • TBI with GCS 13-15

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, State of Vienna, A-1090, Austria

Location

Related Publications (4)

  • 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.

    PMID: 22352906RESULT

  • 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.

    PMID: 25379886RESULT

  • 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.

    PMID: 20883153RESULT

  • 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.

    PMID: 21162128RESULT

Biospecimen

Retention: SAMPLES WITH DNA

7ml serum are drawn from peripheral blood

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Harald Wolf, M.D.

    Department for Trauma Surgery, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Oberarzt Dr. Harald Wolf

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 28, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

AU(1)