Prediction Study of Complications After Severe Trauma (PSCAT)

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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         
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         
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:

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
Syndrome
Wounds and Injuries
Disease
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on October 23, 2014