TraumaNCT01279239
Metabonomics Fingerprinting of Multiple Trauma
An observational study of Trauma, run by Sichuan Academy of Medical Sciences at 1 site in China.
Trial summary
The aim of this study is to establish plasma metabonomics fingerprinting atlas for severe multiple trauma patient using 1H nuclear magnetic resonance (NMR) based metabonomics methodology and advanced mathematics tools. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Jun 2011
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who are suffering from poly trauma.
Who may be able to join
- Age:18-50 years
- Poly trauma
- Injury Severity Score (ISS)>16 and Acute Physiology And Chronic Health Evaluation(APACHE)II>10
Who cannot join
- With comorbidity (Diabetes,Hyperthyroidism or primary organ dysfunction )
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Academy of Medical Sciences, Sichuan Provincial Hospital, Dept. Trauma Surgery
Chengdu, Sichuan, 610101
About this study
Official title: Establishing 1H Nuclear Magnetic Resonance (NMR) Based Metabonomics Fingerprinting Profile for Severe Poly Trauma Patients
The aim of this study is to establish plasma metabonomics fingerprinting atlas for severe multiple trauma patient using 1H nuclear magnetic resonance (NMR) based metabonomics methodology and advanced mathematics tools.
Read the detailed description
Metabonomics is a set of measurements of the dynamic metabolic responses of living systems to stimuli or modifications. This field of study developed from the application of nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry as tools for the study of complex biofluids. Metabonomics is one of the emerging fields of systemic biology researches concerned with the high-throughput identification, quantification and characterization of small molecule metabolites. A metabonomics fingerprinting can be defined as the complete complement of all small molecule (<1500 Da) metabolites found in a specific cell, body fluid, organ or organism.
Severe poly trauma involves complex injuries that consist of multiple pathological mechanisms involving cytotoxic, oxidation stress and immune-endocrine. The complexity of the pathological physiology and biochemistry process are determined not only by the initial mechanical assault, but also by secondary processes including abnormality of inflammation regulation, ischemia, anoxia, free-radical formation, and immune dysfunction that occur over hours and days following the injury. For the clinical perspective, one of the key difficulties is to identify the most at-risk patients who could develop multiple organ failures and consequently death.
This study aims to establish the dynamics of NMR-based metabonomics fingerprinting of severe multi-trauma patients in order to provide a possible multiple organs failure (MOF) or death event prediction.
- Conditions
- Trauma
- Keywords
- Poly Trauma, Metabonomics, NMR, MOF
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Poly trauma | 20 Patients suffering from poly trauma who meet inclusion criteria would be recruited | |
| Healthy control | 20 healthy volunteers would be recruited to obtain basal metabonomics fingerprinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at hospitalization
Measured: Death events from admission to discharge(up to 10 weeks)
Secondary outcomes (1)
Multi Organ Failure(MOF)
Measured: MOF events occurence from admission to discharge(up to 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Hua Jiang, M.D, Study chair, Sichuan Academy of Medical SciencesZhi-Yuan Zhou, M.S, Principal investigator, Sichuan Academy of Medical SciencesMing-Wei Sun, M.D, Principal investigator, Sichuan Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279239
- Sponsor's protocol ID
- META-LAB-10-07-003C-02
- Status last verified
- Jul 2011
- First submitted
- 14 Jan 2011
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing 1H Nuclear Magnetic Resonance (NMR) Based Metabonomics Fingerprinting Profile for Severe Poly Trauma Patients
- ClinicalTrials.gov ID
- NCT01279239
- Acronym / sponsor ID
- META-LAB-10-07-003C-02
- Conditions
- Trauma
- Keywords
- Poly Trauma, Metabonomics, NMR, MOF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sichuan Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Jan 2011 (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.
The aim of this study is to establish plasma metabonomics fingerprinting atlas for severe multiple trauma patient using 1H nuclear magnetic resonance (NMR) based metabonomics methodology and advanced mathematics tools.
Detailed description
Metabonomics is a set of measurements of the dynamic metabolic responses of living systems to stimuli or modifications. This field of study developed from the application of nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry as tools for the study of complex biofluids. Metabonomics is one of the emerging fields of systemic biology researches concerned with the high-throughput identification, quantification and characterization of small molecule metabolites. A metabonomics fingerprinting can be defined as the complete complement of all small molecule (<1500 Da) metabolites found in a specific cell, body fluid, organ or organism.
Severe poly trauma involves complex injuries that consist of multiple pathological mechanisms involving cytotoxic, oxidation stress and immune-endocrine. The complexity of the pathological physiology and biochemistry process are determined not only by the initial mechanical assault, but also by secondary processes including abnormality of inflammation regulation, ischemia, anoxia, free-radical formation, and immune dysfunction that occur over hours and days following the injury. For the clinical perspective, one of the key difficulties is to identify the most at-risk patients who could develop multiple organ failures and consequently death.
This study aims to establish the dynamics of NMR-based metabonomics fingerprinting of severe multi-trauma patients in order to provide a possible multiple organs failure (MOF) or death event prediction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poly trauma | – | –20 Patients suffering from poly trauma who meet inclusion criteria would be recruited |
| Healthy control | – | –20 healthy volunteers would be recruited to obtain basal metabonomics fingerprinting |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who are suffering from poly trauma.
Key inclusion criteria (3 listed)
- Age:18-50 years
- Poly trauma
- Injury Severity Score (ISS)>16 and Acute Physiology And Chronic Health Evaluation(APACHE)II>10
Key exclusion criteria (2 listed)
- With comorbidity (Diabetes,Hyperthyroidism or primary organ dysfunction )
- Pregnancy
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
Mortality at hospitalization
Time frame: Death events from admission to discharge(up to 10 weeks)
1 secondary outcome
Multi Organ Failure(MOF)
Time frame: MOF events occurence from admission to discharge(up to 10 weeks)
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 27 Jul 2011.
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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.
Hua Jiang, M.D study chair
Sichuan Academy of Medical Sciences
Zhi-Yuan Zhou, M.S principal investigator
Sichuan Academy of Medical Sciences
Ming-Wei Sun, M.D principal investigator
Sichuan Academy of Medical Sciences
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, run by Sichuan Academy of Medical Sciences at 1 site in China.
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 3 inclusion and 2 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 27 Jul 2011. 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 China. 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?
Mortality at hospitalization (time frame: Death events from admission to discharge(up to 10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2011; AzTrials last refreshed its copy on 6 Nov 2026.