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Trial record 7 of 316 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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

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

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 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

Resource links provided by the National Library of Medicine


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




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


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639923


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

Publications of Results:
Responsible Party: Harald Wolf, MD, Oberarzt Dr. Harald Wolf, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02639923     History of Changes
Other Study ID Numbers: Wolf-7
First Posted: December 28, 2015    Key Record Dates
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, Traumatic
Wounds and Injuries
Brain Injuries
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating