Clinical trial NCT05799170: Evaluation of the Effectiveness of a Regional Trauma Care System for the Treatment of Patients With Severe Trauma
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 3200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: the mortality of patients with severe trauma
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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