The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury

Completed

• Conditions: Brain Injuries, Traumatic
• Interventions: Procedure: Drawing of 7ml peripheral blood

• Registration Number: NCT02639923
• Lead Sponsor: Harald Wolf, MD

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.

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).

Study Timeline

• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-28
• Study Start: 2016-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-26
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Minor head injury CCT neg. group	Drawing of 7ml peripheral blood	Tbi patients without acute lesion on early cranial computed tomography. Patients consent to have 7ml peripheral blood to be drawn.
Minor head injury CCT pos. group	Drawing of 7ml peripheral blood	Tbi patients with acute lesion on early cranial computed tomography. Patients consent to have 7ml peripheral blood to be drawn.
Control Group (healthy volunteers)	Drawing of 7ml peripheral blood	Volunteers without history, signs or symptoms of acute traumatic injuries. Volunteers consent to have 7ml peripheral blood to be drawn.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria