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NCT02440373 · ClinicalTrials.gov registry record
Plasma Cytochrome c as Biomarker of Traumatic Injury and Predictor of Outcome
A clinical trial of Trauma and Blunt Injury, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- 12
- Enrollment target
- 1
- Study location
NCT02440373: Completed study of Trauma and Blunt Injury, sponsored by Wake Forest University Health Sciences.
NCT02440373 is a study of Trauma and Blunt Injury that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 12 participants, below the 307-participant average among 56 other Trauma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02440373, a study of Trauma and Blunt Injury, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Relationship between plasma levels of cytochrome c and the initial severity of traumatic injury as assessed by the TRISS and the severity of initial presentation based on transfusion requirements and (if available) by blood gas and chemistry analysis along with lactic acid.
Conditions Studied
Study Locations (1)
Illinois
- Advocate Lutheran General Hospital - Park Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-03 |
| Est. Completion | 2017-03 |
What the finished NCT02440373 record still lists
NCT02440373 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 307-participant average among 56 other Trauma trials with a reported enrollment target (96% lower).
The record links to 5 conditions, with Trauma appearing as the primary indexed condition, and to 0 interventions.
NCT02440373 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02440373 about?
NCT02440373 is a clinical study titled "Plasma Cytochrome c as Biomarker of Traumatic Injury and Predictor of Outcome". 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 c...
What is the current status of trial NCT02440373?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2014-03. Estimated completion is 2017-03.
What conditions does trial NCT02440373 study?
This clinical trial studies the following conditions: Trauma, Blunt Injury, Blunt Trauma, Accident, Multiorgan Injury.
Who is sponsoring clinical trial NCT02440373?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02440373 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02440373's enrollment target sits among peer trials
12 55th of 56 higher than 2 of 56 other Trauma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Trauma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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