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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

December 2, 2015
December 28, 2015
March 27, 2017
January 2016
March 2017   (Final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT02639923 on ClinicalTrials.gov Archive Site
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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

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
7ml serum are drawn from peripheral blood
Probability Sample
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).
Brain Injuries, Traumatic
Procedure: Drawing of 7ml peripheral blood
puncture peripheral vein
Other Name: 7ml serum
  • 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.
    Intervention: Procedure: Drawing of 7ml peripheral blood
  • 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.
    Intervention: Procedure: Drawing of 7ml peripheral blood
  • Control Group (healthy volunteers)
    Volunteers without history, signs or symptoms of acute traumatic injuries. Volunteers consent to have 7ml peripheral blood to be drawn.
    Intervention: Procedure: Drawing of 7ml peripheral blood

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Same as current
July 2017
March 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
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
Austria
 
 
NCT02639923
Wolf-7
No
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Harald Wolf, MD, Medical University of Vienna
Harald Wolf, MD
Medical Scientific Fund of the Mayor of Vienna
Principal Investigator: Harald Wolf, M.D. Department for Trauma Surgery, Medical University of Vienna
Medical University of Vienna
March 2017