CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02440373
NCT02440373N/ACompleted

Plasma Cytochrome c as Biomarker of Traumatic Injury and Predictor of Outcome

Wake Forest University Health Sciences·observational·Posted May 12, 2015·Updated Oct 4, 2024

In Brief

An observational study for Trauma and 4 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Cytochrome c is a mitochondrial protein that plays a key role in energy metabolism. When mitochondria are injured, cytochrome c may leave mitochondria and reach the bloodstream. The investigators plan to investigate whether circulating cytochrome c levels may serve as biomarker of traumatic injury correlating with (1) severity of traumatic injury, (2) development of organ dysfunction, and (3) clinical outcomes. The Trauma Services at ALGH will enroll over 8 months 100 consecutive trauma patients who require intubation for mechanical ventilation and survive to hospital admission. The Resuscitation Institute at RFUMS will measure cytochrome c levels in plasma taken upon hospital admission and subsequently at 24, 48, and 72 hours, with additional plasma stored for markers to be defined at a later time. Blood cytochrome c levels will be analyzed in relation to severity of traumatic injury, development of organ dysfunction, and clinical outcomes including survival and functional status (adjusted for covariates such as age, gender, type of trauma, time to stabilization, comorbidities, etc.) using information obtained as part of routine medical care. Successful completion of this project will support blood cytochrome c as biomarker of traumatic injury which could be used to identify severity, predict outcomes, and assess novel mitochondrial protective strategies.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 12, 2015
Enrollment StartMar 1, 2014
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 11.1 years ago