Clinical trial NCT02639923: The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury
Official title: The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries, Traumatic
Keywords: TBI
microRNA
S-100B
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Medical Scientific Fund of the Mayor of Vienna
First posted: 2015-12-28
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Hypothesis: Significant elevation or decrease of the mRNAs miR Let-7i, miR-16 and miR-92 among the study groups
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Department for Trauma Surgery, Medical University of Vienna
name: Harald Wolf, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.