Prediction Study of Complications After Severe Trauma

NCT ID: NCT01713205

Last Updated: 2022-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Trauma is a major public health problem worldwide, ranking as the fourth leading cause of death. One of the most serious complications of major trauma is sepsis, which often induces sequential multiple organ dysfunction syndrome (MODS). There were still no specific biomarkers to predict the susceptibility of complications and outcomes, which leading to the limited prevention methods and the high mortality rate of severe trauma patients. Previous studies from our and other group have found some sepsis and MODS predictors, including genetic polymorphisms, serum cytokines and cell-surface markers. The purposes of this multi-center observational study is to select biomarkers and evaluate a clinically and economically most effective diagnostic algorithm for prediction of complications in severe trauma patients.

Conditions

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Trauma Sepsis Multiple Organ Dysfunction Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role collaborator

Chongqing Emergency Medical Center

OTHER

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Kunming general Hospital of Chengdu Military Region

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital Of Guizhou Medical University

OTHER

Sponsor Role collaborator

Jiang Jianxin

OTHER

Sponsor Role lead

Responsible Party

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Jiang Jianxin

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jianxin Jiang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Guiyang, Guizhou, China

Site Status RECRUITING

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Kunming General Hospital of Chengdu Military Region

Kunming, Yunnan, China

Site Status RECRUITING

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Chongqing Emergency Medical Center

Chongqing, , China

Site Status RECRUITING

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

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Anqiang Zhang, MD

Role: CONTACT

+86-23-68757402

Facility Contacts

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Jin Deng, MD

Role: primary

+86-851-86771474

Xiangjun Bai, MD,PhD

Role: primary

+86-27-83663669

Jiang Hao, MD,PhD

Role: primary

+86-871-64774999

Mao Zhang, MD,PhD

Role: primary

+86-571-87783803

Dingyuan Du, MD,PhD

Role: primary

+86-23-63692110

Lianyang Zhang, MD,PhD

Role: primary

+86-23-68757991

References

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

Reference Type BACKGROUND
PMID: 21274447 (View on PubMed)

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.

Reference Type RESULT
PMID: 21460743 (View on PubMed)

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.

Reference Type RESULT
PMID: 21633947 (View on PubMed)

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.

Reference Type RESULT
PMID: 22047946 (View on PubMed)

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.

Reference Type RESULT
PMID: 22112657 (View on PubMed)

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.

Reference Type RESULT
PMID: 22167001 (View on PubMed)

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.

Reference Type RESULT
PMID: 22266968 (View on PubMed)

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.

Reference Type RESULT
PMID: 24743625 (View on PubMed)

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.

Reference Type RESULT
PMID: 25572180 (View on PubMed)

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.

Reference Type RESULT
PMID: 25880845 (View on PubMed)

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.

Reference Type RESULT
PMID: 27023591 (View on PubMed)

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.

Reference Type RESULT
PMID: 28679406 (View on PubMed)

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.

Reference Type RESULT
PMID: 29920655 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36915009 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34539750 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33624223 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31888703 (View on PubMed)

Other Identifiers

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2012BAI11B01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Jiang-2012BAI11B01

Identifier Type: -

Identifier Source: org_study_id

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