Evaluation of the Effectiveness of a Regional Trauma Care System for the Treatment of Patients With Severe Trauma

Официальное название

Evaluation of the Effectiveness of a Regional Trauma Care System for the Treatment of Patients With Severe Trauma: Protocol for a Prospective, Multicenter, Stepped-wedge Cluster-randomized Controlled Clinical Trial

Обзор

Severe trauma imposes a heavy burden to society and family because of its high mortality and disability rate. Based on the implementation plan of "one region", "two links", and "three teams", the Trauma Medicine Center of Peking University People's Hospital has constructed regional trauma care system that is suitable for China's national conditions. The primary objective of this trial is to evaluate the effectiveness of the regional trauma care system on the treatment of patients with severe trauma in China.This study is a prospective, multicenter, stepped-wedge cluster-randomized controlled clinical trial.

Подробное описание

Background: Severe trauma imposes a heavy burden to society and family because of its high mortality and disability rate. Based on the implementation plan of "one region", "two links", and "three teams", the Trauma Medicine Center of Peking University People's Hospital has constructed regional trauma care system that is suitable for China's national conditions. The primary objective of this trial is to evaluate the effectiveness of the regional trauma care system on the treatment of patients with severe trauma in China.

Methods: This study is a prospective, multicenter, stepped-wedge cluster-randomized controlled clinical trial. Twenty hospitals are selected based on specific eligibility criteria. After the baseline period, 5 randomization steps with 4 hospitals per step will be conducted. Each hospital will gradually enter intervention period in the randomized order for the implementation of regional trauma care system. The initial 1-month is considered as the intervention transition period, during which hospitals are modified and healthcare workers are trained according to the requirements of the regional trauma care system.

Conclusion: This is the first study assessing the effectiveness of the regional trauma care system on the treatment of patients with severe trauma with the conduction a prospective study in China.

Вмешательства

• Другое regional trauma care
  Study intervention is the establishment of in-hospital trauma treatment centers and the formation of regional trauma care system. Regional trauma care system refers to both the establishment of unified and standardized pre-hospital and in-hospital trauma triage and injury classification warning mechanism and the development of unified trauma treatment process and standard in a main government district (population within 1 million), with secondary general hospitals and above that have strong trea

Первичные конечные точки

• the mortality of patients with severe trauma [Срок оценки: one week]

Критерии участия

Критерии включения

• Age of 18-60 years old, with no restriction on gender;
• Severe trauma, including trauma patients with ISS score ≥ 16;
• Time from trauma to admission <24h.

Критерии исключения

• Patients who complicated with underlying diseases, such as malignant tumor and diabetes mellitus;
• Patients with important organ dysfunction before trauma;
• The investigator considers not appropriate for enrollment. -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05799170 · RT study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗