The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury (mRNA)

Harald Wolf, MD

Status: Completed

Conditions: Brain Injuries, Traumatic

Treatments: Procedure: Drawing of 7ml peripheral blood

Study type: Observational

Funder types: Other

Identifiers

NCT02639923

Wolf-7

Details and patient eligibility

About

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.

Full 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).

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

155 participants in 3 patient groups

Minor head injury CCT pos. group

Description:

Tbi patients with acute lesion on early cranial computed tomography. Patients consent to have 7ml peripheral blood to be drawn.

Treatment:

Procedure: Drawing of 7ml peripheral blood

Minor head injury CCT neg. group

Description:

Tbi patients without acute lesion on early cranial computed tomography. Patients consent to have 7ml peripheral blood to be drawn.

Treatment:

Procedure: Drawing of 7ml peripheral blood

Control Group (healthy volunteers)

Description:

Volunteers without history, signs or symptoms of acute traumatic injuries. Volunteers consent to have 7ml peripheral blood to be drawn.

Treatment:

Procedure: Drawing of 7ml peripheral blood