NCT01713205

Brief Summary

The purpose of this study is to evaluate a clinically and economically most effective diagnostic algorithm for prediction of post-traumatic complications in a multicenter sample of severe trauma patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

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

October 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

11.2 years

First QC Date

October 18, 2012

Last Update Submit

July 28, 2022

Conditions

TraumaSepsisMultiple Organ Dysfunction Syndrome

Keywords

trauma ; sepsis; Multiple Organ Dysfunction Syndrome; Prediction; risk

Outcome Measures

Primary Outcomes (1)

  • morbidity rate of complications after trauma (including sepsis and MODS)

    patients will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary Outcomes (1)

  • survival

    witnin 30 days and 60 days after injury

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult severe trauma patients with no serious co-morbidity

You may qualify if:

  • age\> 16 years old and \<65 years old
  • severe trauma patients (AIS ≧3 or ISS≧16)
  • admission within 48 hours after injury
  • given and signed informed consent

You may not qualify if:

  • died within 48h after injury
  • being pregnant or lactating
  • chronic organ dysfunction comorbidities
  • long-term anticoagulant therapy before injury
  • presence of immunosuppression before injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Emergency Surgery, The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

RECRUITING

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Kunming General Hospital of Chengdu Military Region

Kunming, Yunnan, 650032, China

RECRUITING

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Chongqing Emergency Medical Center

Chongqing, 400014, China

RECRUITING

Daping Hospital / Research Institute of Surgery, the Third Military Medical University

Chongqing, 400042, China

RECRUITING

Related Publications (17)

  • Gu W, Jiang J. Genetic polymorphisms and posttraumatic complications. Comp Funct Genomics. 2010;2010:814086. doi: 10.1155/2010/814086. Epub 2011 Jan 11.

    PMID: 21274447BACKGROUND

  • Gu W, Zeng L, Zhang LY, Jiang DP, Du DY, Hu P, Wang HY, Liu Q, Huang SN, Jiang JX. Association of interleukin 4 -589T/C polymorphism with T(H)1 and T(H)2 bias and sepsis in Chinese major trauma patients. J Trauma. 2011 Dec;71(6):1583-7. doi: 10.1097/TA.0b013e3182115034.

    PMID: 21460743RESULT

  • Chen KH, Zeng L, Gu W, Zhou J, Du DY, Jiang JX. Polymorphisms in the toll-like receptor 9 gene associated with sepsis and multiple organ dysfunction after major blunt trauma. Br J Surg. 2011 Sep;98(9):1252-9. doi: 10.1002/bjs.7532. Epub 2011 Jun 1.

    PMID: 21633947RESULT

  • Zeng L, Zhang AQ, Gu W, Chen KH, Jiang DP, Zhang LY, Du DY, Hu P, Huang SN, Wang HY, Jiang JX. Clinical relevance of single nucleotide polymorphisms of the high mobility group box 1 protein gene in patients with major trauma in southwest China. Surgery. 2012 Mar;151(3):427-36. doi: 10.1016/j.surg.2011.07.075. Epub 2011 Nov 1.

    PMID: 22047946RESULT

  • Zhang AQ, Zeng L, Gu W, Zhang LY, Zhou J, Jiang DP, Du DY, Hu P, Yang C, Yan J, Wang HY, Jiang JX. Clinical relevance of single nucleotide polymorphisms within the entire NLRP3 gene in patients with major blunt trauma. Crit Care. 2011;15(6):R280. doi: 10.1186/cc10564. Epub 2011 Nov 23.

    PMID: 22112657RESULT

  • Zeng L, Gu W, Zhang AQ, Zhang M, Zhang LY, Du DY, Huang SN, Jiang JX. A functional variant of lipopolysaccharide binding protein predisposes to sepsis and organ dysfunction in patients with major trauma. Ann Surg. 2012 Jan;255(1):147-57. doi: 10.1097/SLA.0b013e3182389515.

    PMID: 22167001RESULT

  • Zeng L, Zhang AQ, Gu W, Zhou J, Zhang LY, Du DY, Zhang M, Wang HY, Jiang JX. Identification of haplotype tag SNPs within the whole myeloid differentiation 2 gene and their clinical relevance in patients with major trauma. Shock. 2012 Apr;37(4):366-72. doi: 10.1097/SHK.0b013e3182498c8f.

    PMID: 22266968RESULT

  • Zhang AQ, Gu W, Zeng L, Zhang LY, Du DY, Zhang M, Hao J, Yue CL, Jiang J. Genetic variants of microRNA sequences and susceptibility to sepsis in patients with major blunt trauma. Ann Surg. 2015 Jan;261(1):189-96. doi: 10.1097/SLA.0000000000000687.

    PMID: 24743625RESULT

  • Zeng L, Du J, Gu W, Zhang AQ, Wang HY, Wen DL, Qiu L, Yang XT, Sun JH, Zhang M, Hao J, Jiang JX. Rs1800625 in the receptor for advanced glycation end products gene predisposes to sepsis and multiple organ dysfunction syndrome in patients with major trauma. Crit Care. 2015 Jan 9;19(1):6. doi: 10.1186/s13054-014-0727-2.

    PMID: 25572180RESULT

  • Pan W, Zhang AQ, Gu W, Gao JW, Du DY, Zhang LY, Zeng L, Du J, Wang HY, Jiang JX. Identification of haplotype tag single nucleotide polymorphisms within the nuclear factor-kappaB family genes and their clinical relevance in patients with major trauma. Crit Care. 2015 Mar 20;19(1):95. doi: 10.1186/s13054-015-0836-6.

    PMID: 25880845RESULT

  • Gao JW, Zeng L, Zhang AQ, Wang X, Pan W, Du DY, Zhang LY, Gu W, Jiang JX. Identification of Haplotype Tag Single-Nucleotide Polymorphisms within the PPAR Family Genes and Their Clinical Relevance in Patients with Major Trauma. Int J Environ Res Public Health. 2016 Mar 26;13(4):374. doi: 10.3390/ijerph13040374.

    PMID: 27023591RESULT

  • Zhang H, Lu Y, Sun G, Teng F, Luo N, Jiang J, Wen A. The common promoter polymorphism rs11666254 downregulates FPR2/ALX expression and increases risk of sepsis in patients with severe trauma. Crit Care. 2017 Jul 6;21(1):171. doi: 10.1186/s13054-017-1757-3.

    PMID: 28679406RESULT

  • Zhang A, Gu W, Lu H, Zeng L, Zhang L, Du D, Hao J, Wen D, Wang X, Jiang J. Genetic contribution of suppressor of cytokine signalling polymorphisms to the susceptibility to infection after traumatic injury. Clin Exp Immunol. 2018 Oct;194(1):93-102. doi: 10.1111/cei.13160. Epub 2018 Sep 9.

    PMID: 29920655RESULT

  • Wang J, Wen D, Zeng S, Du J, Cui L, Sun J, Chen G, Zeng L, Du D, Zhang L, Deng J, Jiang J, Zhang A. Cytokine Biomarker Phenotype for Early Prediction and Triage of Sepsis in Blunt Trauma Patients. J Surg Res. 2023 Mar;283:824-832. doi: 10.1016/j.jss.2022.10.059. Epub 2022 Dec 5.

    PMID: 36915009DERIVED

  • Sun J, Zhang H, Liu D, Cui L, Wang Q, Gan L, Wen D, Wang J, Du J, Huang H, Zhang A, Deng J, Jiang J, Zeng L. A Functional Variant of CXCL16 Is Associated With Predisposition to Sepsis and MODS in Trauma Patients: Genetic Association Studies. Front Genet. 2021 Sep 3;12:720313. doi: 10.3389/fgene.2021.720313. eCollection 2021.

    PMID: 34539750DERIVED

  • Lu H, Zhang A, Wen D, Du J, Sun J, Qiao L, Du D, Gu W, Jiang J. Plasma Vanin-1 as a Novel Biomarker of Sepsis for Trauma Patients: A Prospective Multicenter Cohort Study. Infect Dis Ther. 2021 Jun;10(2):739-751. doi: 10.1007/s40121-021-00414-w. Epub 2021 Feb 23.

    PMID: 33624223DERIVED

  • Lu H, Wen D, Sun J, Zeng L, Du J, Du D, Zhang L, Deng J, Jiang J, Zhang A. Enhancer polymorphism rs10865710 associated with traumatic sepsis is a regulator of PPARG gene expression. Crit Care. 2019 Dec 30;23(1):430. doi: 10.1186/s13054-019-2707-z.

    PMID: 31888703DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, urine and tissue

MeSH Terms

Conditions

Wounds and InjuriesSepsisMultiple Organ Failure

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Jianxin Jiang, MD,PhD

    Daping Hospital/Research Institute of Surgery, Third Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anqiang Zhang, MD

CONTACT

+86-23-68757402zhanganqiang@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2012

First Posted

October 24, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

August 1, 2022

Record last verified: 2022-07

Locations

CN(6)