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临床试验/NCT06007807
NCT06007807已完成不适用

Registry of Patients With Severe Trauma Admitted to the ICU in Tarragona

Hospital Universitari Joan XXIII de Tarragona.1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
1
主要终点
ICU mortality

研究概览

简要总结

Severe trauma is one of the leading causes of morbidity, mortality, and disability worldwide. Currently, it is the primary cause of death among individuals under 45 years of age. This disease, considered a "silent pandemic," exhibits heterogeneous physiopathology and unequal geographic distribution in terms of the type of injuries. The prognosis of subjects who have suffered severe trauma is uncertain, especially in patients with traumatic brain injury.

The epidemiology of severe trauma has undergone changes in recent years due to the global aging of society, resulting in different populations with older ages and more associated comorbidities. These factors are frequently linked to the use of chronic treatments such as antiplatelet agents or anticoagulants, which could worsen traumatic hemorrhage-the leading preventable cause of death following severe trauma. Despite efforts for primary prevention, such as road safety campaigns and occupational risk prevention, the annual incidence of severe trauma cases worldwide remains high. Enhancing the management of trauma patients would significantly influence the final clinical outcomes.

Given the aforementioned, it is of vital importance to understand the local epidemiology of severe trauma for the development of clinical research. This constitutes an effective tool to investigate changes in clinical practices, improve prevention strategies, and determine the global burden of the disease.

The hypothesis of the IcuTrauma Project is to create a territorial Registry of adults with severe trauma admitted to the ICU to understand the local epidemiology in Tarragona (Spain). This initiative would facilitate new lines of clinical research aimed at improving outcomes and the quality of care for trauma patients.

详细描述

  • Study design: observational, retrospective, one centre (Hospital Universitari Joan XXIII) in Tarragona, Catalonia, Spain.
  • Study period: Seven-years period: Since 01 January 2015 - 31 December 2022 (The registry will be open and active recruiting after this time point).
  • Sample size calculation: Not applicable. The sample size will be equal to the total number of patients consecutively admitted to the Intensive Care Unit (ICU) due to severe trauma during the study period.
  • Data extraction:

Data will be extracted by twofold:

  1. Hand-driven: extracted data from the medical reports by reviewing the clinical history system performed by the study investigators, who are part of the staff of the ICU involved in the care of trauma patients. This information was collected into a large-scale database and, once introduced, the data was checked and verified by two investigators (and principal investigator).

These manually extracted data included pre-hospital variables (such as the time of the injury, the mechanism of injury, first vital signs, pre-hospital procedures), in-hospital information (demographic's, primary survey of trauma in emergency department-ED, use of Extended Focused Assesment with Sonography in Trauma, complete laboratory results in ED), description of detailed anatomic injuries (Traumatic Brain Injury-TBI, thoracic trauma, abdominal trauma, Pelvic trauma, orthopedic injuries), severity scores (Acute Physiology And Chronic Health Evaluation-APACHE II, Sequential Organ Failure Assessment-SOFA score, Injury Severity Score-ISS, Abbreviated Injury Score-AIS, etc), resources during ICU admission (surgeries, transfusions, organ support, etc), complications (organ failures and nosocomial infections such as ventilator-associated pneumonia, catheter-related infection, etc), and clinical outcomes (ICU mortality, cause of death, in-hospital mortality, one-year survival, mechanical ventilation days, ICU and hospital length of stay, disability at ICU discharge and destination at discharge. 2. Automatic data: automated data collected with the Electronic Health System (Centricity Critical Care) provide solid and valid extraction of information. Automatic variables were checked and validated by the expert and specialized members of the ICU in data quality assessment and the management of data to ensure that recorded information was reliable. The accuracy, completeness and representativeness of automatic data was double checked when entered into the large-scale database for data quality by the principal investigator and a biotechnologist, who were responsible for the quality assurance plan that addressed data validation, monitoring and auditing (identifying inconsistencies, outliers or incorrect ranges for variables entered into the registry). The automated variables collected (not recorded manually) included demographic data, comorbidities and previous risk factors, dates (hospital and ICU admission, hospital and ICU discharge), laboratory tests during the first week of ICU admission, resources consumption during ICU stay, complications during ICU admission and outcomes.

  • Statistical plan: descriptive and analytical statistics using binary logistic regression (for association), survival analysis with Kaplan Meier analysis and Cox regression (for clinical outcomes), nonlinear association test such as CHAID decision analysis and restricted cubic splines, and matching learning analysis (for cluster or subgroups identification). These analyzes will be carried out using SPSS v24 and R software. Missing data values of automated variables will be handled using multiple imputation. Hand-driven data had negligible missing values.
  • Variable definitions (all definitions met the ATLS-Advanced Trauma Life Support criteria):

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults who were consecutevely admitted to the ICU for severe trauma during the study period.

排除标准

  • Children aged < 15 years old.
  • Trauma admitted outside the ICU

结局指标

主要结局

ICU mortality

时间窗: Time (in days) between ICU admission date and ICU discharge date

proportion of deaths

次要结局

  • Length of stay (LOS)(Time (in days) between hospital admission date and hospital discharge date)
  • Mechanical ventilation duration(During the invasive mechanical ventilation treatment)
  • In-hospital mortality(at 28 day)

研究者

发起方
Hospital Universitari Joan XXIII de Tarragona.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gerard Moreno

PhD, Staff of Intensive Care Unit

Hospital Universitari Joan XXIII de Tarragona.

研究点 (1)

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