Prediction Study of Complications After Severe Trauma (PSCAT)

Identifying Severe Trauma Patients at High Risk of Post-traumatic Complications

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Trauma; Multiple Organ Dysfunction Syndrome

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 3500

Contacts and Locations

• Study Contact: Name: Anqiang Zhang, MD; Phone Number: +86-23-68757402; Email: zhanganqiang@126.com

Study Locations

• China
  • Chongqing, China, 400014
    • Recruiting
    • Chongqing Emergency Medical Center
    • Contact: Dingyuan Du, MD，PhD; Phone Number: +86-23-63692110; Email: dudingyuan@qq.com.cn
    • Principal Investigator: Dingyuan Du, MD，PhD
  • Chongqing, China, 400042
    • Recruiting
    • Daping Hospital / Research Institute of Surgery, the Third Military Medical University
    • Contact: Lianyang Zhang, MD,PhD; Phone Number: +86-23-68757991; Email: hapzhangly@163.com
    • Principal Investigator: Lianyang Zhang, MD，PhD
    • Principal Investigator: Jianxin Jiang, MD，PhD
  • Guizhou
    • Guiyang, Guizhou, China, 550004
      • Recruiting
      • Department of Emergency Surgery, The Affiliated Hospital of Guizhou Medical University
      • Contact: Jin Deng, MD; Phone Number: +86-851-86771474; Email: Dengjin6067@126.com
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Huazhong University of Science and Technology
      • Contact: Xiangjun Bai, MD,PhD; Phone Number: +86-27-83663669; Email: baixiangjun@hotmail.com
      • Principal Investigator: Xiangjun Bai, MD,PhD
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Recruiting
      • Kunming General Hospital of Chengdu Military Region
      • Contact: Jiang Hao, MD,PhD; Phone Number: +86-871-64774999; Email: kmlmhj@sina.com
      • Principal Investigator: Jiang Hao, MD,PhD
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Mao Zhang, MD,PhD; Phone Number: +86-571-87783803; Email: zmhz@hotmail.com
      • Principal Investigator: Mao Zhang, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult severe trauma patients with no serious co-morbidity

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
survival	witnin 30 days and 60 days after injury

Collaborators and Investigators

• Sponsor: Jiang Jianxin
• Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University; Huazhong University of Science and Technology; The Affiliated Hospital Of Guizhou Medical University; Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; Chongqing Emergency Medical Center; Kunming general Hospital of Chengdu Military Region
• Investigators: Principal Investigator: Jianxin Jiang, MD,PhD, Daping Hospital/Research Institute of Surgery, Third Military Medical University

Publications and helpful links

General Publications

• Gu W, Jiang J. Genetic polymorphisms and posttraumatic complications. Comp Funct Genomics. 2010;2010:814086. doi: 10.1155/2010/814086. Epub 2011 Jan 11.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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;19:6. doi: 10.1186/s13054-014-0727-2.
• 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-κB family genes and their clinical relevance in patients with major trauma. Crit Care. 2015 Mar 20;19:95. doi: 10.1186/s13054-015-0836-6.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (Estimate): October 24, 2012

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: trauma ; sepsis; Multiple Organ Dysfunction Syndrome; Prediction; risk
• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Wounds and Injuries; Multiple Organ Failure
• Other Study ID Numbers: Jiang-2012BAI11B01; 2012BAI11B01 (Other Grant/Funding Number: Five-twelfth National Science and Technology Support Program)