TraumaNCT02440373
Plasma Cytochrome c as Biomarker of Traumatic Injury and Predictor of Outcome
An observational study of Trauma and Blunt Injury, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Blunt Injury, Blunt Trauma
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients of both genders suffering acute non-penetrating traumatic injury.
Who may be able to join
- 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.
Who cannot join
- Known disease with life expectancy <6 months. Penetrating mechanism for the primary injury. Death within 4 hours from hospital arrival.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
About this study
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.
Read the detailed description
The investigators propose to determine whether plasma cytochrome c could serve as clinical biomarker of traumatic injury by examining the relationship between plasma levels of cytochrome c and the severity of the initial injury upon arrival to the hospital, subsequent development of organ dysfunction, and clinical outcomes. Cytochrome c is a mitochondrial protein that plays a crucial role in energy metabolism enabling transfer of electrons from complex III (i.e., cytochrome c reductase) to complex IV (cytochrome c oxidase). Upon mitochondrial injury and contingent on severity, cytochrome c may be released to the cytosol and subsequently to the bloodstream. The rationale for this project stems from: (1) observations at the Resuscitation Institute in animal models of cardiac arrest and resuscitation in which plasma cytochrome c correlates directly with the severity of post-resuscitation left ventricular dysfunction and inversely with survival and (2) observations by others reporting a correlation between plasma cytochrome c and severity of organ injury. The investigators hypothesize that plasma cytochrome c measured upon arrival to the hospital reflects the severity of the initial traumatic injury resulting from the aggregate effects of direct injury to organs, ischemic injury consequent to blood loss, delays in stabilization, and preexistent comorbidity - all factors that can injure mitochondria. The investigators further hypothesize that the initial cytochrome c plasma level combined with the levels measured during the subsequent three days of hospitalization correlate with the development of organ dysfunction, and clinical outcomes. The current proposal is structured in three specific aims:
Specific Aim 1 (collection of blood samples and clinical data): For this aim the investigator plans to enroll 100 consecutive trauma victims admitted to Advocate Lutheran General Hospital (ALGH) over a period of 8 months presenting with single or multisystem injuries and meeting specific entry and exclusion criteria developed to ensure a broad range of injury severity. Blood will be sampled within 15 minutes of hospital arrival (e.g., in the Emergency Department or Operating Room) and subsequently at 24, 48, and 72 hours. Plasma will be separated and stored at -80 °C for subsequent batch measurement of cytochrome c (and other markers of mitochondrial injury that may become available at the time of analysis) in the Resuscitation Institute at Rosalind Franklin Univer-sity of Medicine and Science (RFUMS). Clinical data will be extracted from tools used clinically - including the Illinois Trauma Registry Worksheet and the medical record - and used to: (i) record severity of initial traumatic injury by calculating the Trauma Score - Injury Severity Score (TRISS) along with a detailed assessment of individual organs injury; (ii) estimate the severity of blood loss based on base deficit and transfusion needs; (iii) determine subsequent development of organ dysfunction by calculating the Multiple Organ Dysfunction Score (MODS) and the Sequential Organ Failure Score; and (iv) assess outcomes by measuring length of stay in the Intensive Care Unit (ICU), length of stay in the hospital, survival upon hospital discharge, and functional status upon hospital discharge.
Specific Aim 2 (analysis of plasma cytochrome c): Frozen samples of arterial plasma, stored at -80°C at ALGH, will be transferred to the Resuscitation Institute at RFU and cytochrome c measured using electrochemiluminescence.
Specific Aim 3 (statistical analysis and modeling): A database devoid of patient identifiers will be created merging the clinical information with values of plasma cytochrome c levels and other markers as they become available. Considering the pilot nature of the project, statistical modeling and analysis will be primarily exploratory focused on identifying relationships between plasma cytochrome c levels upon hospital arrival and clinical elements contributing of the severity of primary traumatic injury. The analysis and modeling will also include examining the predictive value of the initial and subsequent plasma cytochrome c levels on development of organ dysfunction and clinical outcomes.
The long-term goal of the project is to develop plasma cytochrome c as biomarker of traumatic injury and other clinical conditions associated with mitochondrial injury that could be used at the bedside - i.e., after developing point of care assays - for (1) assessing severity of illness, (2) prognostication of outcome, and (3) clinical re-search on novel therapeutic interventions aimed at reducing mitochondrial injury.
- Conditions
- Trauma, Blunt Injury, Blunt Trauma, Accident, Multiorgan Injury
- Medical subject headings
- Wounds and Injuries, Wounds, Nonpenetrating
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day one.
Secondary outcomes (2)
Plasma cytochrome c levels in relation to development of organ dysfunction and hospital outcomes
Relationship between plasma levels of cytochrome c and subsequent development of organ dysfunction assessed by daily measurements of MODS and SOFA and various clinical outcomes including length of stay in ICU and in the hospital, survival to hospital discharge, and functional status upon discharge.
Measured: From hospital admission until the date of discharge from the hospital, up to 26 weeks.
Individual organ contribution to plasma cytochrome c levels
Contribution of individual organs injured to plasma cytochrome c levels (e.g., liver injury is likely to produce greater mitochondrial injury that thoracic injury given the greater mitochondrial density in liver tissue).
Measured: From hospital admission until the date of the last cytochrome c measurement (i.e., day three from hospital admission).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMar 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Rosalind Franklin University of Medicine and Science
- Responsible party
- Sponsor
- Investigators
- Raul Gazmuri, MD, Principal investigator, Rosalind Franklin University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440373
- Sponsor's protocol ID
- AHC IRB# 5458
- Status last verified
- Mar 2018
- First submitted
- 28 Apr 2015
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Bertini I, Cavallaro G, Rosato A. Cytochrome c: occurrence and functions. Chem Rev. 2006 Jan;106(1):90-115. doi: 10.1021/cr050241v. No abstract available.
PubMed 16402772Giege P, Grienenberger JM, Bonnard G. Cytochrome c biogenesis in mitochondria. Mitochondrion. 2008 Jan;8(1):61-73. doi: 10.1016/j.mito.2007.10.001. Epub 2007 Oct 11.
PubMed 18033741Radhakrishnan J, Wang S, Ayoub IM, Kolarova JD, Levine RF, Gazmuri RJ. Circulating levels of cytochrome c after resuscitation from cardiac arrest: a marker of mitochondrial injury and predictor of survival. Am J Physiol Heart Circ Physiol. 2007 Feb;292(2):H767-75. doi: 10.1152/ajpheart.00468.2006. Epub 2006 Oct 13.
PubMed 17040974Ow YP, Green DR, Hao Z, Mak TW. Cytochrome c: functions beyond respiration. Nat Rev Mol Cell Biol. 2008 Jul;9(7):532-42. doi: 10.1038/nrm2434.
PubMed 18568041Radhakrishnan J, Kolarova JD, Ayoub IM, Gazmuri RJ. AVE4454B--a novel sodium-hydrogen exchanger isoform-1 inhibitor--compared less effective than cariporide for resuscitation from cardiac arrest. Transl Res. 2011 Feb;157(2):71-80. doi: 10.1016/j.trsl.2010.11.004. Epub 2010 Dec 15.
PubMed 21256459Alleyne T, Joseph J, Sampson V. Cytochrome-c detection: a diagnostic marker for myocardial infarction. Appl Biochem Biotechnol. 2001 Feb;90(2):97-105. doi: 10.1385/abab:90:2:97.
PubMed 11297391Renz A, Burek C, Mier W, Mozoluk M, Schulze-Osthoff K, Los M. Cytochrome c is rapidly extruded from apoptotic cells and detectable in serum of anticancer-drug treated tumor patients. Adv Exp Med Biol. 2001;495:331-4. doi: 10.1007/978-1-4615-0685-0_46. No abstract available.
PubMed 11774588Adachi N, Hirota M, Hamaguchi M, Okamoto K, Watanabe K, Endo F. Serum cytochrome c level as a prognostic indicator in patients with systemic inflammatory response syndrome. Clin Chim Acta. 2004 Apr;342(1-2):127-36. doi: 10.1016/j.cccn.2003.12.011.
PubMed 15026273Barczyk K, Kreuter M, Pryjma J, Booy EP, Maddika S, Ghavami S, Berdel WE, Roth J, Los M. Serum cytochrome c indicates in vivo apoptosis and can serve as a prognostic marker during cancer therapy. Int J Cancer. 2005 Aug 20;116(2):167-73. doi: 10.1002/ijc.21037.
PubMed 15800951Hosoya M, Nunoi H, Aoyama M, Kawasaki Y, Suzuki H. Cytochrome c and tumor necrosis factor-alpha values in serum and cerebrospinal fluid of patients with influenza-associated encephalopathy. Pediatr Infect Dis J. 2005 May;24(5):467-70. doi: 10.1097/01.inf.0000160995.07461.b8.
PubMed 15876954Hosoya M, Kawasaki Y, Katayose M, Sakuma H, Watanabe M, Igarashi E, Aoyama M, Nunoi H, Suzuki H. Prognostic predictive values of serum cytochrome c, cytokines, and other laboratory measurements in acute encephalopathy with multiple organ failure. Arch Dis Child. 2006 Jun;91(6):469-72. doi: 10.1136/adc.2005.078436. Epub 2006 Jan 27.
PubMed 16443616Sakaida I, Kimura T, Yamasaki T, Fukumoto Y, Watanabe K, Aoyama M, Okita K. Cytochrome c is a possible new marker for fulminant hepatitis in humans. J Gastroenterol. 2005 Feb;40(2):179-85. doi: 10.1007/s00535-004-1517-4.
PubMed 15770402Marshall JC, Cook DJ, Christou NV, Bernard GR, Sprung CL, Sibbald WJ. Multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome. Crit Care Med. 1995 Oct;23(10):1638-52. doi: 10.1097/00003246-199510000-00007.
PubMed 7587228Cook R, Cook D, Tilley J, Lee K, Marshall J; Canadian Critical Care Trials Group. Multiple organ dysfunction: baseline and serial component scores. Crit Care Med. 2001 Nov;29(11):2046-50. doi: 10.1097/00003246-200111000-00002.
PubMed 11700393Jacobs S, Zuleika M, Mphansa T. The Multiple Organ Dysfunction Score as a descriptor of patient outcome in septic shock compared with two other scoring systems. Crit Care Med. 1999 Apr;27(4):741-4. doi: 10.1097/00003246-199904000-00027.
PubMed 10321663
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Cytochrome c as Biomarker of Traumatic Injury and Predictor of Outcome
- ClinicalTrials.gov ID
- NCT02440373
- Acronym / sponsor ID
- AHC IRB# 5458
- Conditions
- Trauma, Blunt Injury, Blunt Trauma, Accident, Multiorgan Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Rosalind Franklin University of Medicine and Science
- Study start
- Mar 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators propose to determine whether plasma cytochrome c could serve as clinical biomarker of traumatic injury by examining the relationship between plasma levels of cytochrome c and the severity of the initial injury upon arrival to the hospital, subsequent development of organ dysfunction, and clinical outcomes. Cytochrome c is a mitochondrial protein that plays a crucial role in energy metabolism enabling transfer of electrons from complex III (i.e., cytochrome c reductase) to complex IV (cytochrome c oxidase). Upon mitochondrial injury and contingent on severity, cytochrome c may be released to the cytosol and subsequently to the bloodstream. The rationale for this project stems from: (1) observations at the Resuscitation Institute in animal models of cardiac arrest and resuscitation in which plasma cytochrome c correlates directly with the severity of post-resuscitation left ventricular dysfunction and inversely with survival and (2) observations by others reporting a correlation between plasma cytochrome c and severity of organ injury. The investigators hypothesize that plasma cytochrome c measured upon arrival to the hospital reflects the severity of the initial traumatic injury resulting from the aggregate effects of direct injury to organs, ischemic injury consequent to blood loss, delays in stabilization, and preexistent comorbidity - all factors that can injure mitochondria. The investigators further hypothesize that the initial cytochrome c plasma level combined with the levels measured during the subsequent three days of hospitalization correlate with the development of organ dysfunction, and clinical outcomes. The current proposal is structured in three specific aims:
Specific Aim 1 (collection of blood samples and clinical data): For this aim the investigator plans to enroll 100 consecutive trauma victims admitted to Advocate Lutheran General Hospital (ALGH) over a period of 8 months presenting with single or multisystem injuries and meeting specific entry and exclusion criteria developed to ensure a broad range of injury severity. Blood will be sampled within 15 minutes of hospital arrival (e.g., in the Emergency Department or Operating Room) and subsequently at 24, 48, and 72 hours. Plasma will be separated and stored at -80 °C for subsequent batch measurement of cytochrome c (and other markers of mitochondrial injury that may become available at the time of analysis) in the Resuscitation Institute at Rosalind Franklin Univer-sity of Medicine and Science (RFUMS). Clinical data will be extracted from tools used clinically - including the Illinois Trauma Registry Worksheet and the medical record - and used to: (i) record severity of initial traumatic injury by calculating the Trauma Score - Injury Severity Score (TRISS) along with a detailed assessment of individual organs injury; (ii) estimate the severity of blood loss based on base deficit and transfusion needs; (iii) determine subsequent development of organ dysfunction by calculating the Multiple Organ Dysfunction Score (MODS) and the Sequential Organ Failure Score; and (iv) assess outcomes by measuring length of stay in the Intensive Care Unit (ICU), length of stay in the hospital, survival upon hospital discharge, and functional status upon hospital discharge.
Specific Aim 2 (analysis of plasma cytochrome c): Frozen samples of arterial plasma, stored at -80°C at ALGH, will be transferred to the Resuscitation Institute at RFU and cytochrome c measured using electrochemiluminescence.
Specific Aim 3 (statistical analysis and modeling): A database devoid of patient identifiers will be created merging the clinical information with values of plasma cytochrome c levels and other markers as they become available. Considering the pilot nature of the project, statistical modeling and analysis will be primarily exploratory focused on identifying relationships between plasma cytochrome c levels upon hospital arrival and clinical elements contributing of the severity of primary traumatic injury. The analysis and modeling will also include examining the predictive value of the initial and subsequent plasma cytochrome c levels on development of organ dysfunction and clinical outcomes.
The long-term goal of the project is to develop plasma cytochrome c as biomarker of traumatic injury and other clinical conditions associated with mitochondrial injury that could be used at the bedside - i.e., after developing point of care assays - for (1) assessing severity of illness, (2) prognostication of outcome, and (3) clinical re-search on novel therapeutic interventions aimed at reducing mitochondrial injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients of both genders suffering acute non-penetrating traumatic injury.
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- Known disease with life expectancy <6 months. Penetrating mechanism for the primary injury. Death within 4 hours from hospital arrival.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma cytochrome c levels in relation to severity of traumatic injury
Time frame: Day one.
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.
2 secondary outcomes
Plasma cytochrome c levels in relation to development of organ dysfunction and hospital outcomes
Time frame: From hospital admission until the date of discharge from the hospital, up to 26 weeks.
Individual organ contribution to plasma cytochrome c levels
Time frame: From hospital admission until the date of the last cytochrome c measurement (i.e., day three from hospital admission).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 16402772Bertini I, Cavallaro G, Rosato A. Cytochrome c: occurrence and functions. Chem Rev. 2006 Jan;106(1):90-115. doi: 10.1021/cr050241v. No abstract available.
- Background: PubMed 18033741Giege P, Grienenberger JM, Bonnard G. Cytochrome c biogenesis in mitochondria. Mitochondrion. 2008 Jan;8(1):61-73. doi: 10.1016/j.mito.2007.10.001. Epub 2007 Oct 11.
- Background: PubMed 17040974Radhakrishnan J, Wang S, Ayoub IM, Kolarova JD, Levine RF, Gazmuri RJ. Circulating levels of cytochrome c after resuscitation from cardiac arrest: a marker of mitochondrial injury and predictor of survival. Am J Physiol Heart Circ Physiol. 2007 Feb;292(2):H767-75. doi: 10.1152/ajpheart.00468.2006. Epub 2006 Oct 13.
- Background: PubMed 18568041Ow YP, Green DR, Hao Z, Mak TW. Cytochrome c: functions beyond respiration. Nat Rev Mol Cell Biol. 2008 Jul;9(7):532-42. doi: 10.1038/nrm2434.
- Background: PubMed 21256459Radhakrishnan J, Kolarova JD, Ayoub IM, Gazmuri RJ. AVE4454B--a novel sodium-hydrogen exchanger isoform-1 inhibitor--compared less effective than cariporide for resuscitation from cardiac arrest. Transl Res. 2011 Feb;157(2):71-80. doi: 10.1016/j.trsl.2010.11.004. Epub 2010 Dec 15.
- Background: PubMed 11297391Alleyne T, Joseph J, Sampson V. Cytochrome-c detection: a diagnostic marker for myocardial infarction. Appl Biochem Biotechnol. 2001 Feb;90(2):97-105. doi: 10.1385/abab:90:2:97.
- Background: PubMed 11774588Renz A, Burek C, Mier W, Mozoluk M, Schulze-Osthoff K, Los M. Cytochrome c is rapidly extruded from apoptotic cells and detectable in serum of anticancer-drug treated tumor patients. Adv Exp Med Biol. 2001;495:331-4. doi: 10.1007/978-1-4615-0685-0_46. No abstract available.
- Background: PubMed 15026273Adachi N, Hirota M, Hamaguchi M, Okamoto K, Watanabe K, Endo F. Serum cytochrome c level as a prognostic indicator in patients with systemic inflammatory response syndrome. Clin Chim Acta. 2004 Apr;342(1-2):127-36. doi: 10.1016/j.cccn.2003.12.011.
- Background: PubMed 15800951Barczyk K, Kreuter M, Pryjma J, Booy EP, Maddika S, Ghavami S, Berdel WE, Roth J, Los M. Serum cytochrome c indicates in vivo apoptosis and can serve as a prognostic marker during cancer therapy. Int J Cancer. 2005 Aug 20;116(2):167-73. doi: 10.1002/ijc.21037.
- Background: PubMed 15876954Hosoya M, Nunoi H, Aoyama M, Kawasaki Y, Suzuki H. Cytochrome c and tumor necrosis factor-alpha values in serum and cerebrospinal fluid of patients with influenza-associated encephalopathy. Pediatr Infect Dis J. 2005 May;24(5):467-70. doi: 10.1097/01.inf.0000160995.07461.b8.
- Background: PubMed 16443616Hosoya M, Kawasaki Y, Katayose M, Sakuma H, Watanabe M, Igarashi E, Aoyama M, Nunoi H, Suzuki H. Prognostic predictive values of serum cytochrome c, cytokines, and other laboratory measurements in acute encephalopathy with multiple organ failure. Arch Dis Child. 2006 Jun;91(6):469-72. doi: 10.1136/adc.2005.078436. Epub 2006 Jan 27.
- Background: PubMed 15770402Sakaida I, Kimura T, Yamasaki T, Fukumoto Y, Watanabe K, Aoyama M, Okita K. Cytochrome c is a possible new marker for fulminant hepatitis in humans. J Gastroenterol. 2005 Feb;40(2):179-85. doi: 10.1007/s00535-004-1517-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raul Gazmuri, MD principal investigator
Rosalind Franklin University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Blunt Injury, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma cytochrome c levels in relation to severity of traumatic injury (time frame: Day one.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02440373, which also lists 52 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.