NCT01279239

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 27, 2011

Status Verified

July 1, 2011

Enrollment Period

1 year

First QC Date

January 14, 2011

Last Update Submit

July 26, 2011

Conditions

Trauma

Keywords

Poly TraumaMetabonomicsNMRMOF

Outcome Measures

Primary Outcomes (1)

  • Mortality at hospitalization

    Death events from admission to discharge(up to 10 weeks)

Secondary Outcomes (1)

  • Multi Organ Failure(MOF)

    MOF events occurence from admission to discharge(up to 10 weeks)

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who are suffering from poly trauma.

You may qualify if:

  • Age:18-50 years
  • Poly trauma
  • Injury Severity Score (ISS)\>16 and Acute Physiology And Chronic Health Evaluation(APACHE)II\>10

You may not qualify if:

  • With comorbidity (Diabetes,Hyperthyroidism or primary organ dysfunction )
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Academy of Medical Sciences, Sichuan Provincial Hospital, Dept. Trauma Surgery

Chengdu, Sichuan, 610101, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma from peripheral blood.

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Hua Jiang, M.D

    Sichuan Academy of Medical Sciences

    STUDY CHAIR

  • Zhi-Yuan Zhou, M.S

    Sichuan Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Ming-Wei Sun, M.D

    Sichuan Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 19, 2011

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 27, 2011

Record last verified: 2011-07

Locations

CN(1)