NCT03974048

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

June 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1.9 years

First QC Date

May 29, 2019

Last Update Submit

November 8, 2021

Conditions

TraumaInjuries

Keywords

EpigeneticsDNA methylationTrauma

Outcome Measures

Primary Outcomes (1)

  • Immediate DNA methylation profile

    Immediate (\< 4 hours) post-trauma DNA methylation profile in blood cells compared to the pre-surgery (baseline) and immediate post-surgery (\< 4 hours) DNA methylation profile in blood cells.

    Day of trauma/surgery

Secondary Outcomes (7)

  • Pre-trauma/-surgery DNA methylation profile

    Pre-trauma/surgery

  • Stability of DNA methylation profile

    30-45 days after trauma/surgery

  • Change in DNA methylation profile; pre-trauma/-surgery to post-trauma/-surgery

    Day of trauma/surgery

  • Change in DNA methylation profile; immediately post-trauma/-surgery to one month post-trauma/-surgery

    0 to 30-45 days after trauma/surgery

  • DNA methylation changes in relation to injury severity

    Day 0-45 after trauma/surgery

  • +2 more secondary outcomes

Study Arms (2)

Trauma patients

All trauma patients admitted to Rigshospitalet's trauma center will have a blood sample taken during the initial treatment and 30 days after the trauma.

Diagnostic Test: Blood samples for DNA methylation analysis

Patients admitted for elective orthopedic surgery

The patients will have a blood sample taken before and after surgery and again 30 days after the surgery.

Diagnostic Test: Blood samples for DNA methylation analysis

Interventions

Blood samples for DNA methylation analysisDIAGNOSTIC_TEST

DNA from blood samples will be isolated and analyzed for genome-wide DNA methylation patterns using the Infinium HumanMethylationEPIC BeadChip (Illumina, San Diego, CA, USA).

Patients admitted for elective orthopedic surgeryTrauma patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consists of all trauma patients admitted to RH's trauma center generating a trauma team activation. The control group will consist of patients admitted to RH's orthopedic department for elective surgery.

You may qualify if:

  • Age 18-65 years.
  • Trauma patients: Admitted to Rigshospitalet's trauma center generating a trauma team activation.
  • Surgical controls: Admitted for elective surgery (non-traumatic cause) at the orthopedics department AND
  • Only one surgical procedure planned from study day 0 to study day 45.
  • Expected procedure length of at least 60 minutes.

You may not qualify if:

  • Not able to obtain informed consent and not possible to obtain consent from a next-of-kin.
  • Trauma patients:
  • Secondary transfers.
  • Pre-hospital blood transfusion OR blood transfusion in the trauma center before the first blood sample is obtained.
  • First blood sample taken later than 4 hours after the trauma.
  • Patients in cardiac arrest before/after hospital admission.
  • Surgical controls:
  • Surgical procedures due to cancer or fractures.
  • First post-operative blood sample taken later than 4 hours after surgical end time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are obtained from patients to investigate DNA methylation profiles

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Blood Specimen CollectionDNA Methylation

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesMethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic Phenomena

Study Officials

  • Jacob Steinmetz, MD, Ph.D.

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 29, 2019

First Posted

June 4, 2019

Study Start

June 3, 2019

Primary Completion

April 15, 2021

Study Completion

August 1, 2021

Last Updated

November 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)