An observational study in Trauma Injury and Trauma, Multiple, sponsored by Wonju Severance Christian Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by Wonju Severance Christian Hospital · Observational
Therefore, this study aimed to:
i. prospectively analyze the effectiveness of DNI by measuring the degree of inflammation in severely injured patients;
ii. Measure serum mitochondrial DNA, which is suggested as a mechanism preceding DNI elevation, and identify the sequence of inflammatory steps leading to circulating mitochondrial DNA as a damage-associated molecular pattern (DAMP), DNI, neutrophils, and inflammatory cytokines; and
iii. Establish the effectiveness of each indicator as a prognostic factor, construct a prediction model for poor prognosis, and prove the effectiveness of the final risk model.
Study period and patients recruitment
i. 1st and 2nd year (until construction of prognostic scoring system): 200 patients (MODS:50, mortality: 50)
ii. 3rd year (for validation): 100 patients (MODS: 30, mortality: 30)
Measurement of serum mtDNA copy number, DNI, and inflammatory cytokines
i. Blood sampling: At the initial presentation and again on trauma days #1 and #2.
ii. smtDNAcn, cytokines (IL-1β/2/6/12, IFN-ℽ, TNF-α, IL-4/10) by PCR, multiplex, and DNI using an automatic cell analyzer.
Analysis of correlation between biologic markers and poor outcomes (MODS, mortality)
i. Statistical analysis of inflammatory markers such as smtDNAcn, cytokines (IL-1β/2/6/12, IFN-ℽ, TNF-α, IL-4/10) measured at the initial presentation, on trauma day #1, and #2 between severely injured patients with no poor outcomes and those with poor outcomes such as MODS and mortality risk.
Risk model construction using inflammatory markers to predict MODS and mortality risk
i. Recruitment of 100 severely injured patients for validation on 3rd year during study period
ii. The recruited patients were divided into low-risk and high-risk groups according to the new risk model, cut-off value of each inflammatory marker, and SOFA score.
iii. Comparison of sensitivity and specificity of the new risk model, inflammatory markers, and SOFA score.
128 studies on the registry are indexed under Accidental Injuries; 39 are open to participants now.
This study's enrollment of 89 is below the median of 170 across 59 observational studies indexed under Accidental Injuries.
Browse Accidental Injuries studies →Wonju Severance Christian Hospital is the lead sponsor of 43 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All severely injured patients with injury severiry score ≥ 16 older than 19 years of age who visited Wonju Severance Christian Hospital, regional trauma center will be included in the study
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Mortality (dichotomous)
The number of deaths
Time frame: Within 30 days after trauma
Multiorgan distress syndrome (dichotomous)
The number of patients with SOFA ≥ 6
Time frame: Within 30 days after trauma
Hospital length of stay (continuous)
Measured in days from admission to discharge
Time frame: From date of the admission until the date of first discharge from the hospital, assessed up to 60 days
Intensive care unit (ICU) stay (continuous)
Measured in days from ICU admission to ICU out
Time frame: From date of ICU admission (in cases of ICU admission at the initial presentation) until the date of first discharge from ICU, assessed up to 60 days
Plan to share: Undecided
Ran from Jul 2022 to primary completion in Jun 2024, 22 months.
Of 33 non-industry observational studies under Accidental Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's 22 months is close to that.
Counting every sponsor, half of 39 studies reached it within 31 months; a quarter within 12 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Wonju Severance Christian Hospital