TraumaPSCATNCT01713205
Prediction Study of Complications After Severe Trauma
An observational study of Trauma and Sepsis, run by Jiang Jianxin at 6 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Sepsis, Multiple Organ Dysfunction Syndrome
- How many people
- 3,500 participants
- Where
- 6 sitesChina
- Study dates
- Oct 2012to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult severe trauma patients with no serious co-morbidity
Who may be able to join
- 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
Who cannot join
- died within 48h after injury
- being pregnant or lactating
- chronic organ dysfunction comorbidities
- long-term anticoagulant therapy before injury
- presence of immunosuppression before injury
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Chongqing Emergency Medical Center
Chongqing, 400014
Dingyuan Du, MD，PhD, +86-23-63692110, dudingyuan@qq.com.cn
Dingyuan Du, MD，PhD
- Recruiting
Daping Hospital / Research Institute of Surgery, the Third Military Medical University
Chongqing, 400042
Lianyang Zhang, MD,PhD, +86-23-68757991, hapzhangly@163.com
Lianyang Zhang, MD，PhD
- Recruiting
Department of Emergency Surgery, The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
Jin Deng, MD, +86-851-86771474, Dengjin6067@126.com
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Mao Zhang, MD,PhD, +86-571-87783803, zmhz@hotmail.com
Mao Zhang, MD,PhD
- Recruiting
Kunming General Hospital of Chengdu Military Region
Kunming, Yunnan, 650032
Jiang Hao, MD,PhD, +86-871-64774999, kmlmhj@sina.com
Jiang Hao, MD,PhD
- Recruiting
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Xiangjun Bai, MD,PhD, +86-27-83663669, baixiangjun@hotmail.com
Xiangjun Bai, MD,PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Trauma, Sepsis, Multiple Organ Dysfunction Syndrome
- Keywords
- trauma ; sepsis; Multiple Organ Dysfunction Syndrome; Prediction; risk
- Medical subject headings
- Wounds and Injuries, Sepsis, Multiple Organ Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity rate of complications after trauma (including sepsis and MODS)
Measured: patients will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes (1)
survival
Measured: witnin 30 days and 60 days after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiang Jianxin
- Sponsor type
- University, hospital or other
- 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, Zhejiang University, School of Medicine, Kunming general Hospital of Chengdu Military Region, The Affiliated Hospital Of Guizhou Medical University
- Responsible party
- Sponsor-investigator, Jiang Jianxin, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Jianxin Jiang, MD,PhD, Principal investigator, Daping Hospital/Research Institute of Surgery, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713205
- Sponsor's protocol ID
- Jiang-2012BAI11B01
- Other IDs
- 2012BAI11B01
- Acronym
- PSCAT
- Status last verified
- Jul 2022
- First submitted
- 18 Oct 2012
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21274447Gu 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.
PubMed 21460743Chen 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.
PubMed 21633947Zeng 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.
PubMed 22047946Zhang 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.
PubMed 22112657Zeng 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.
PubMed 22167001Zeng 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.
PubMed 22266968Zhang 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.
PubMed 24743625Zeng 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.
PubMed 25572180Pan 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.
PubMed 25880845Gao 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.
PubMed 27023591Zhang 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.
PubMed 28679406Zhang 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.
PubMed 29920655Wang 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.
PubMed 36915009Sun 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.
PubMed 34539750
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Severe Trauma Patients at High Risk of Post-traumatic Complications
- ClinicalTrials.gov ID
- NCT01713205
- Acronym / sponsor ID
- PSCAT / Jiang-2012BAI11B01
- Conditions
- Trauma, Sepsis, Multiple Organ Dysfunction Syndrome
- Keywords
- trauma ; sepsis; Multiple Organ Dysfunction Syndrome; Prediction; risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Jiang JianxinUniversity, hospital or other
- 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, Zhejiang University, School of Medicine, Kunming general Hospital of Chengdu Military Region, The Affiliated Hospital Of Guizhou Medical University
- Study start
- Oct 2012
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult severe trauma patients with no serious co-morbidity
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- died within 48h after injury
- being pregnant or lactating
- chronic organ dysfunction comorbidities
- long-term anticoagulant therapy before injury
- presence of immunosuppression before injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
survival
Time frame: witnin 30 days and 60 days after injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Background: PubMed 21274447Gu W, Jiang J. Genetic polymorphisms and posttraumatic complications. Comp Funct Genomics. 2010;2010:814086. doi: 10.1155/2010/814086. Epub 2011 Jan 11.
- Results publication: PubMed 21460743Gu 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.
- Results publication: PubMed 21633947Chen 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.
- Results publication: PubMed 22047946Zeng 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.
- Results publication: PubMed 22112657Zhang 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.
- Results publication: PubMed 22167001Zeng 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.
- Results publication: PubMed 22266968Zeng 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.
- Results publication: PubMed 24743625Zhang 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.
- Results publication: PubMed 25572180Zeng 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.
- Results publication: PubMed 25880845Pan 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.
- Results publication: PubMed 27023591Gao 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.
- Results publication: PubMed 28679406Zhang 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.
Related trials for Trauma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianxin Jiang, MD,PhD principal investigator
Daping Hospital/Research Institute of Surgery, Third Military Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Sepsis, run by Jiang Jianxin at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anqiang Zhang, MD (+86-23-68757402, zhanganqiang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01713205, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.