NCT02639923

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
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: Harald Wolf, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Brain Injuries, Traumatic

Interventions

Type	Name	Description
PROCEDURE	Drawing of 7ml peripheral blood	puncture peripheral vein

Timeline

• Start date: 2016-01-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2015-12-28
• Last updated: 2022-12-28

Locations

1 site across 1 country: Austria