Prediction Study of Complications After Severe Trauma

• Conditions: Multiple Organ Dysfunction Syndrome; Sepsis; Trauma

• Registration Number: NCT01713205
• Lead Sponsor: Jiang Jianxin

Brief 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.

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-24
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-01
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
survival	witnin 30 days and 60 days after injury

Trial Locations

Locations (6)

Department of Emergency Surgery, The Affiliated Hospital of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China

Tongji Hospital, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Kunming General Hospital of Chengdu Military Region; 🇨🇳 Kunming, Yunnan, China

Chongqing Emergency Medical Center; 🇨🇳 Chongqing, China

Daping Hospital / Research Institute of Surgery, the Third Military Medical University; 🇨🇳 Chongqing, China