Prediction Study of Complications After Severe Trauma (PSCAT)

This study is currently recruiting participants.

Verified October 2012 by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Sponsor:

Collaborators:

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

Chongqing Emergency Medical Center

Huazhong University of Science and Technology

Second Affiliated Hospital, School of Medicine, Zhejiang University

Information provided by (Responsible Party):

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

ClinicalTrials.gov Identifier:

NCT01713205

First received: October 18, 2012

Last updated: October 22, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition
Trauma Sepsis Multiple Organ Dysfunction Syndrome

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Identifying Severe Trauma Patients at High Risk of Post-traumatic Complications

Resource links provided by NLM:

MedlinePlus related topics: Injuries Sepsis Wounds

U.S. FDA Resources

Further study details as provided by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:

Primary Outcome Measures:

morbidity rate of complications after trauma (including sepsis and MODS) [ Time Frame: patients will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

survival [ Time Frame: witnin 30 days and 60 days after injury ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

whole blood, serum, white cells, urine and tissue

Estimated Enrollment:	2000
Study Start Date:	October 2012
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Adult severe trauma patients with no serious co-morbidity

Criteria

Inclusion Criteria:

age> 16 years old and <85 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713205

Contacts

Contact: Wei Gu, MD,PhD

+86-23-68757402

clgwjm@163.com

Locations

China, Hubei
Tongji Hospital, Huazhong University of Science and Technology	Not yet recruiting
Wuhan, Hubei, China, 430030
Contact: Xiangjun Bai, MD,PhD +86-27-83663669 baixiangjun@hotmail.com
Principal Investigator: Xiangjun Bai, MD,PhD
China, Zhejiang
Second Affiliated Hospital, School of Medicine, Zhejiang University	Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Mao Zhang, MD,PhD +86-571-87783803 zmhz@hotmail.com
Principal Investigator: Mao Zhang, MD,PhD
China
Daping Hospital / Research Institute of Surgery, the Third Military Medical University	Recruiting
Chongqing, China, 400042
Contact: Lianyang Zhang, MD,PhD +86-23-68757991 hapzhangly@163.com
Principal Investigator: Lianyang Zhang, MD，PhD
Principal Investigator: Jianxin Jiang, MD，PhD
Chongqing Emergency Medical Center	Recruiting
Chongqing, China, 400014
Contact: Dingyuan Du, MD，PhD +86-23-63692110 dudingyuan@yahoo.com.cn
Principal Investigator: Dingyuan Du, MD，PhD

Sponsors and Collaborators

Jiang Jianxin

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

Chongqing Emergency Medical Center

Huazhong University of Science and Technology

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Principal Investigator:

Jianxin Jiang, MD,PhD

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

More Information

Publications:

Gu W, Jiang J. Genetic polymorphisms and posttraumatic complications. Comp Funct Genomics. 2010;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.

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. 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. 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.

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.

Responsible Party:	Jiang Jianxin, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier:	NCT01713205 History of Changes
Other Study ID Numbers:	Jiang-2012BAI11B01, 2012BAI11B01
Study First Received:	October 18, 2012
Last Updated:	October 22, 2012
Health Authority:	China: Ministry of Science and Technology

Keywords provided by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:

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

Additional relevant MeSH terms:

Multiple Organ Failure
Sepsis
Wounds and Injuries
Shock

Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on May 16, 2013

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