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临床试验/NCT06323096
NCT06323096招募中不适用

Разработка системы поддержки принятия клинических решений для тяжелых больных с политравмой

Semey State Medical University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Prediction of SIRS

研究概览

简要总结

The goal of this observational study is to develop a Clinical Decision Support System for severe patients with polytrauma. The main questions it aims to answer are:

  • Is it possible to predict the development of systemic inflammatory response syndrome for the next 24 h after admission?
  • Is it possible to predict the development of blood loss >25% of blood volume for the next 24 h after admission?
  • Is it possible to predict the development of acute traumatic coagulopathy for the next 24 h after admission?
  • Is it possible to predict the development of pneumonia in polytrauma patients?
  • Is it possible to predict the outcome in polytrauma patients?

No intervention is planned for this study.

详细描述

This study aimed to develop a Clinical Decision Support System for the management of severe polytrauma patients at the early inpatient care stage.

Scientific Hypothesis: It is assumed that the use of a clinical decision Support System at the stage of early inpatient care may reduce the mortality rate and adverse outcomes in severe patients with polytrauma.

Study setting The study is planned as a multicenter, non-interventional study, with participation from clinics providing inpatient trauma care for patients with polytrauma. The participating clinics will be selected based on their ability to provide access to a large and diverse population of patients with polytrauma. The research subgroup will be determined by clinics in compliance with the necessary ethical standards. The study will be conducted both retrospectively and prospectively, with data collection spanning a period of at least two years. Retrospective data will be collected from patients' medical records, including information on patient demographics, injury characteristics, diagnostic tests, and treatment modalities. Prospective data will be obtained through standardized patient interviews and clinical assessments, including patient-reported outcomes, clinical measures of physical and psychological functioning, and healthcare utilization. All participating clinics will be required to comply with the rules of medical ethics and deontology as well as local regulations governing access to personal data. In addition, researchers will be required to obtain informed consent from patients or their legal representatives before collecting any data for the study.

Obtained data:

Gender, Age, AIS code for every registered injury, NISS, Vitals on Admission (pulse rate, systolic and diastolic blood pressure, respiratory rate), Complete Blood Count on Admission (Red Blood Cells, Hematocrit, Hemoglobin, Platelets, White Blood Cells), biochemical analysis of blood on admission (total protein, total bilirubin, glucose, urea, creatinine), Blood Coagulation test (Activated Partial Thromboplastin Time, International Normalized Ratio, Fibrinogen), amount of total transfused blood and plasma packs, presence of complications (systemic inflammatory response syndrome, shock, severe hemorrhage [>25% of blood loss], acute traumatic coagulopathy, respiratory distress, pneumonia), length of stay in hospital, length of stay in the intensive care unit, and outcome at hospital discharge.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

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

入选标准

  • Availability of informed consent, signed by the patient or his legal representative;
  • Patients over 18 years of age;
  • Expanded criteria of the new Berlin definition of polytrauma: patients who comply with three conditions:
  • Presence of damage to one area of the body with an AIS score ≥3 points.
  • Presence of damage to ≥2 areas of the body with an AIS score of ≥
  • Presence of ≥1 physiological risk factors and/or primary hospitalization in the ICU.
  • Completeness of the medical record in terms of laboratory and instrumental studies and protocol of therapeutic and surgical treatment.

排除标准

  • Refusal to participate in the study at any stage.
  • Death within one hour after hospitalization.
  • Missing data.
  • Patients who seek primary care 24 hours after injury.
  • Patients requiring transfer between profiles and hospitals for implementation of rehabilitation or other stages of therapy.
  • Patients with prematurely interrupted treatment.
  • Trauma combined with suffocation, drowning, frostbite, electrical trauma, or chemical and/or thermal burns.
  • Patients with pathological fractures.
  • Pregnant women.
  • Cases with predominantly severe craniocephalic (GCS <7 points) or spinal injury (deep paresis and plegias).

结局指标

主要结局

Prediction of SIRS

时间窗: By the end of January 2024

Rate of SIRS prediction in the 24 h after admission using the developed CDSS.

Rate of hemorrage prediction in the 24 h after admission using the developed CDSS.

时间窗: By the end of January 2024

Rate of hemorrage prediction in the 24 h after admission using the developed CDSS.

Rate of ATC prediction in the 24 h after admission using the developed CDSS.

时间窗: By the end of January 2024

Rate of ATC prediction in the 24 h after admission using the developed CDSS.

Rate of pneumonia prediction using the developed CDSS.

时间窗: By the end of January 2024

Rate of pneumonia prediction within all period of admission using the developed CDSS.

次要结局

未报告次要终点

研究者

发起方
Semey State Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Prokazyuk

MD, Anesthesiology and ICU specialist

Semey State Medical University

研究点 (1)

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