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

NCT02440373 | Completed

• 1 other identifier: AHC IRB# 5458
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trauma; Blunt Injury; Blunt Trauma; Accident; Multiorgan Injury

Outcome Measures

Primary Outcomes (1)

• Plasma cytochrome c levels in relation to severity of traumatic injury

  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.

  Day one.

Secondary Outcomes (2)

• Plasma cytochrome c levels in relation to development of organ dysfunction and hospital outcomes

  From hospital admission until the date of discharge from the hospital, up to 26 weeks.

• Individual organ contribution to plasma cytochrome c levels

  From hospital admission until the date of the last cytochrome c measurement (i.e., day three from hospital admission).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients of both genders suffering acute non-penetrating traumatic injury.

You may qualify if:

• Age 18 years or older. Blunt mechanism for the primary injury. Time from injury to hospital arrival is ≤ 2 hours Mechanical ventilation for any reason, including surgery, within the initial 24 hours from hospital arrival.
• Any one of the following:
• Systolic blood pressure \<90 mmHg (Class III shock- \>30 %blood loss) within 4 hours from hospital arrival.
• Base deficit \> 4 mmol/l in the first blood gas upon hospital arrival
• Transfusion of ≥ 2 units of packed red blood cells within ≤12 hours from hospital arrival.

You may not qualify if:

• Known disease with life expectancy \<6 months. Penetrating mechanism for the primary injury. Death within 4 hours from hospital arrival.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Rosalind Franklin University of Medicine and Science: collaborator

Study Sites (1)

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Related Publications (52)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood drawn within 15 minutes of arrival to the Emergency Department and at 24, 48, and 74 hours. Each sample will be processed and stored for subsequent analysis of cytochrome c and other markers of mitochondrial injury that may become available at a later time.

MeSH Terms

Conditions

Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Raul Gazmuri, MD

  Rosalind Franklin University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 12, 2015
• Study Start: March 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: October 4, 2024

Record last verified: 2018-03

Locations

US (1)