Prediction Study of Complications After Severe Trauma

Sepsis Clinical Trial

— PSCAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01713205
• Other study ID #: Jiang-2012BAI11B01
• Secondary ID: 2012BAI11B01
• Status: Recruiting
• Start date: October 2012
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Anqiang Zhang, MD
• Phone: +86-23-68757402
• Email: zhanganqiang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Organ Dysfunction Syndrome
• Multiple Organ Failure
• Sepsis
• Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
China	Chongqing Emergency Medical Center	Chongqing
China	Daping Hospital / Research Institute of Surgery, the Third Military Medical University	Chongqing
China	Department of Emergency Surgery, The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Kunming General Hospital of Chengdu Military Region	Kunming	Yunnan
China	Tongji Hospital, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (7)

Lead Sponsor	Collaborator
Jiang Jianxin	Chongqing Emergency Medical Center, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Huazhong University of Science and Technology, Kunming general Hospital of Chengdu Military Region, Second Affiliated Hospital, School of Medicine, Zhejiang University, The Affiliated Hospital Of Guizhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (13)

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. — View Citation

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 Hea — View Citation

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

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.0b — View Citation

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-?B family genes and their clinical relevance in patients with major trauma. Crit Car — View Citation

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 — View Citation

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. — View Citation

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. 2 — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	survival		witnin 30 days and 60 days after injury