Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT01713205
Status:
UNKNOWN
Last Update Posted:
2022-08-01
First Post:
2012-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction Study of Complications After Severe Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, serum, white cells, urine and tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2012-10-18', 'studyFirstSubmitQcDate': '2012-10-22', 'lastUpdatePostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morbidity rate of complications after trauma (including sepsis and MODS)', 'timeFrame': 'patients will be followed for the duration of hospital stay, an expected average of 3 weeks'}], 'secondaryOutcomes': [{'measure': 'survival', 'timeFrame': 'witnin 30 days and 60 days after injury'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['trauma ; sepsis; Multiple Organ Dysfunction Syndrome; Prediction; risk'], 'conditions': ['Trauma', 'Sepsis', 'Multiple Organ Dysfunction Syndrome']}, 'referencesModule': {'references': [{'pmid': '21274447', 'type': 'BACKGROUND', '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.'}, {'pmid': '21460743', 'type': 'RESULT', '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.0b013e3182115034.'}, {'pmid': '21633947', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '22047946', 'type': 'RESULT', '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. 2012 Mar;151(3):427-36. doi: 10.1016/j.surg.2011.07.075. Epub 2011 Nov 1.'}, {'pmid': '22112657', 'type': 'RESULT', '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: 10.1186/cc10564. Epub 2011 Nov 23.'}, {'pmid': '22167001', 'type': 'RESULT', '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.0b013e3182389515.'}, {'pmid': '22266968', 'type': 'RESULT', '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: 10.1097/SHK.0b013e3182498c8f.'}, {'pmid': '24743625', 'type': 'RESULT', '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.'}, {'pmid': '25572180', 'type': 'RESULT', '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. Crit Care. 2015 Jan 9;19(1):6. doi: 10.1186/s13054-014-0727-2.'}, {'pmid': '25880845', 'type': 'RESULT', '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-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.'}, {'pmid': '27023591', 'type': 'RESULT', '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 Health. 2016 Mar 26;13(4):374. doi: 10.3390/ijerph13040374.'}, {'pmid': '28679406', 'type': 'RESULT', '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.'}, {'pmid': '29920655', 'type': 'RESULT', '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: 10.1111/cei.13160. Epub 2018 Sep 9.'}, {'pmid': '36915009', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34539750', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33624223', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '31888703', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult severe trauma patients with no serious co-morbidity', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\> 16 years old and \\<65 years old\n* severe trauma patients (AIS ≧3 or ISS≧16)\n* admission within 48 hours after injury\n* given and signed informed consent\n\nExclusion Criteria:\n\n* died within 48h after injury\n* being pregnant or lactating\n* chronic organ dysfunction comorbidities\n* long-term anticoagulant therapy before injury\n* presence of immunosuppression before injury'}, 'identificationModule': {'nctId': 'NCT01713205', 'acronym': 'PSCAT', 'briefTitle': 'Prediction Study of Complications After Severe Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'Identifying Severe Trauma Patients at High Risk of Post-traumatic Complications', 'orgStudyIdInfo': {'id': 'Jiang-2012BAI11B01'}, 'secondaryIdInfos': [{'id': '2012BAI11B01', 'type': 'OTHER_GRANT', 'domain': 'Five-twelfth National Science and Technology Support Program'}]}, 'contactsLocationsModule': {'locations': [{'zip': '550004', 'city': 'Guiyang', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Deng, MD', 'role': 'CONTACT', 'email': 'Dengjin6067@126.com', 'phone': '+86-851-86771474'}], 'facility': 'Department of Emergency Surgery, The Affiliated Hospital of Guizhou Medical University', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangjun Bai, MD,PhD', 'role': 'CONTACT', 'email': 'baixiangjun@hotmail.com', 'phone': '+86-27-83663669'}, {'name': 'Xiangjun Bai, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tongji Hospital, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '650032', 'city': 'Kunming', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiang Hao, MD,PhD', 'role': 'CONTACT', 'email': 'kmlmhj@sina.com', 'phone': '+86-871-64774999'}, {'name': 'Jiang Hao, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kunming General Hospital of Chengdu Military Region', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mao Zhang, MD,PhD', 'role': 'CONTACT', 'email': 'zmhz@hotmail.com', 'phone': '+86-571-87783803'}, {'name': 'Mao Zhang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '400014', 'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dingyuan Du, MD，PhD', 'role': 'CONTACT', 'email': 'dudingyuan@qq.com.cn', 'phone': '+86-23-63692110'}, {'name': 'Dingyuan Du, MD，PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chongqing Emergency Medical Center', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '400042', 'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lianyang Zhang, MD,PhD', 'role': 'CONTACT', 'email': 'hapzhangly@163.com', 'phone': '+86-23-68757991'}, {'name': 'Lianyang Zhang, MD，PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jianxin Jiang, MD，PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Daping Hospital / Research Institute of Surgery, the Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Anqiang Zhang, MD', 'role': 'CONTACT', 'email': 'zhanganqiang@126.com', 'phone': '+86-23-68757402'}], 'overallOfficials': [{'name': 'Jianxin Jiang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daping Hospital/Research Institute of Surgery, Third Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiang Jianxin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, {'name': 'Chongqing Emergency Medical Center', 'class': 'OTHER'}, {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, {'name': 'Kunming general Hospital of Chengdu Military Region', 'class': 'UNKNOWN'}, {'name': 'The Affiliated Hospital Of Guizhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jiang Jianxin', 'investigatorAffiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}}}}