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

• ClinicalTrials.gov Identifier: NCT02639923
• Recruitment Status: Unknown
• First Posted: December 28, 2015
• Last Update Posted: March 27, 2017
• Sponsor: Harald Wolf, MD
• Collaborator: Medical Scientific Fund of the Mayor of Vienna
• Information provided by (Responsible Party): Harald Wolf, MD, Medical University of Vienna

Study Description

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.

Condition or disease	Intervention/treatment
Brain Injuries, Traumatic	Procedure: Drawing of 7ml peripheral blood

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 Design

• Study Type: Observational
• Estimated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury A Pilot Study
• Study Start Date: January 2016
• Estimated Primary Completion Date: March 2017
• Estimated Study Completion Date: July 2017

Groups and Cohorts

Group/Cohort	Intervention/treatment
Minor head injury CCT pos. group; Tbi patients with acute lesion on early cranial computed tomography. Patients consent to have 7ml peripheral blood to be drawn.	Procedure: Drawing of 7ml peripheral blood; puncture peripheral vein; Other Name: 7ml serum
Minor head injury CCT neg. group; Tbi patients without acute lesion on early cranial computed tomography. Patients consent to have 7ml peripheral blood to be drawn.	Procedure: Drawing of 7ml peripheral blood; puncture peripheral vein; Other Name: 7ml serum
Control Group (healthy volunteers); Volunteers without history, signs or symptoms of acute traumatic injuries. Volunteers consent to have 7ml peripheral blood to be drawn.	Procedure: Drawing of 7ml peripheral blood; puncture peripheral vein; Other Name: 7ml serum

Outcome Measures

Primary Outcome Measures :

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

Biospecimen Retention:   Samples With DNA

7ml serum are drawn from peripheral blood

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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).

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.

Contacts and Locations

Contacts

Contact: Harald Wolf, M.D.; +43140400 ext 59010; harald.wolf@meduniwien.ac.at

Contact: Harald Widhalm, M.D.; +43140400 ext 59010; harald.widhalm@meduniwien.ac.at

Locations

Austria

Medical University of Vienna; Recruiting

Vienna, Austria, A-1090

Contact: Harald Wolf, M.D. +43140400 ext 5959 harald.wolf@meduniwien.ac.at

Contact: Harald K Widhalm, M.D. +43140400 ext 59010 harald.widhalm@meduniwien.ac.at

Sponsors and Collaborators

Harald Wolf, MD

Medical Scientific Fund of the Mayor of Vienna

Investigators

• Principal Investigator: Harald Wolf, M.D.; Department for Trauma Surgery, Medical University of Vienna

More Information

Publications of Results:

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.

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.

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.

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.

• Responsible Party: Harald Wolf, MD, Oberarzt Dr. Harald Wolf, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT02639923
• Other Study ID Numbers: Wolf-7
• First Posted: December 28, 2015
• Last Update Posted: March 27, 2017
• Last Verified: March 2017

Keywords provided by Harald Wolf, MD, Medical University of Vienna:

TBI; microRNA; S-100B

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating