The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury

The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury A Pilot Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02639923

Acronym

mRNA

Enrollment

155

Registered

2015-12-28

Start date

2016-01-01

Completion date

2021-12-01

Last updated

2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Traumatic

Keywords

TBI, microRNA, S-100B

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.

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): 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).

Interventions

PROCEDUREDrawing of 7ml peripheral blood

puncture peripheral vein

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* TBI with GCS 13-15

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Hypothesis: Significant elevation or decrease of the mRNAs miR Let-7i, miR-16 and miR-92 among the study groups	6 hours	non of the measured biomarker shows a significant difference between the 3 study groups

Countries

Austria

Contacts

PRINCIPAL_INVESTIGATORHarald Wolf, M.D.

Department for Trauma Surgery, Medical University of Vienna

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026