Clinical Trials Logo
  1. Home
  2. Trauma
  3. NCT03974048

Identification of the Epigenetic Response to Trauma — TrauMeth  

Trauma Clinical Trial

Official title:
Identification of the Epigenetic Response to Trauma - a Prospective, Observational Study

Clinical Trial Summary

The objective of this study is to investigate potential early alterations in the DNA methylation profile after severe trauma and to investigate if the early marks persist.

Clinical Trial Description

Background: Severe trauma is an extreme physical exposure, which may have significant consequences for the patient. In addition to anatomical injury and hemodynamic compromise, severe trauma causes an immense and rapid systemic immune reaction. At the genomic level, trauma has been found to significantly increase gene expression in circulating leukocytes, and preliminary data is also emerging that trauma may even cause epigenetic (DNA methylation) alterations. Epigenetics, including DNA methylation, have been suggested as a mediator of genetic risk and to play a significant role in subsequent non-traumatic disease. Within the field of trauma DNA methylation has only been sparsely studied, but a few studies of traumatized animals have suggested that DNA methylation alterations may occur in relation to trauma. Even though DNA methylation is highly dynamic, some marks have been found to be stable over time, and thus may have long-term consequences. An increasing understanding of the role of epigenetics in disease development and response may pave the way for new treatment targets and modalities for multiple diseases including trauma. Research question: Does trauma induce immediate (<4 hours) and persistent (30 days post-trauma) changes in the epigenome of peripheral blood cells, and do epigenetic changes correlate with patient recovery? Objectives: To identify potential early alterations in the DNA methylation profile after severe trauma AND to investigate if the early marks persist. Study design: A prospective, observational, cohort study of trauma patients admitted to RH's trauma center. The trauma cohort will be compared to a cohort of patients admitted for elective orthopedic surgery in terms of DNA methylation profile in blood cells pre-trauma/surgery, immediately post-trauma/surgery, and 30-45 days post-trauma/surgery. DNA methylation profiles will be assessed by array technique using Illumina's MethylationEPIC Bead-Chip. Primary outcome: Immediate (<4 hours) post-trauma DNA methylation profile in blood cells. Secondary outcomes: Pre-trauma/surgery DNA methylation profile, change in DNA methylation from pre-trauma/surgery to immediately and 30 days post-trauma/surgery, occurrence of organ dysfunction, sepsis, septic shock, 30-day mortality, ICU admission > 24 hours, ICU length of stay (LOS), hospital LOS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03974048
Study type Observational
Source Rigshospitalet, Denmark
Contact
Status Completed
Phase
Start date June 3, 2019
Completion date August 1, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Terminated NCT03781817 - Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures Phase 4
Completed NCT04342416 - Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women N/A
Recruiting NCT04856449 - DBT Skills Plus EMDR for BPD and Trauma N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Recruiting NCT04725721 - Testing FIRST in Youth Outpatient Psychotherapy N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT03696563 - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS N/A
Withdrawn NCT03249129 - Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Completed NCT02240732 - Surgical Tourniquets and Cerebral Emboli N/A
Completed NCT02227979 - Effects of PURPLE Cry Intervention N/A
Withdrawn NCT01169025 - Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT03112304 - Child STEPS for Youth Mental Health in Maine Sustainability N/A
Completed NCT01475344 - Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC) Phase 1/Phase 2
Completed NCT01210417 - Trauma Heart to Arm Time N/A
Completed NCT01201863 - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy Phase 4