Medical University of Vienna
Vienna, State of Vienna, A-1090, Austria
NCT Number: NCT02639923
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.
During the study, technical and scientific capabilities and options increased and two further mRNA´S (miR-124-3p and miR-9-5p) will be investigated, too.
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Notify Me18 year and older
All sexes
Observational
Vienna, State of Vienna, A-1090, Austria
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):
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
puncture peripheral vein
Other names: 7ml serum
Time frame: 6 hours
non of the measured biomarker shows a significant difference between the 3 study groups
Harald Wolf, MD
Other
The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury A Pilot Study
Acronym: mRNA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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