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临床试验/NCT04561050
NCT04561050已完成不适用

Prediction of Massive Transfusion in Trauma Patients in Prehospital and In-hospital: Data From Swiss Trauma Registry (STR)

Centre Hospitalier Universitaire Vaudois1 个研究点 分布在 1 个国家目标入组 13,222 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13,222
试验地点
1
主要终点
Presence of Massive transfusion

研究概览

简要总结

Since the 2000s, many prognostic scores were developed to predict traumatic haemorrhage. Most of these studies were retrospectives based on registers. Due to missing data on death due to bleeding, these studies chose to predict the massive transfusion risk as a surrogate of haemorrhagic death. These scores include clinical parameters (vital signs), laboratory values (Haemoglobin, lactate, Base excess) and/or imaging (CT or ultrasound) values. The scores showing best performance are the Trauma Associated Severe Haemorrhage (TASH) score, developed and validated on the German register (DGU-Register) and the ABC score developed and validated in the United States of America.

However, the majority of these scores cannot be applied at the trauma scene due to the unavailability of laboratory and imaging values. Therefore, their clinical utility remains unclear. To overcome the need for diagnostic tests, authors have developed and recently validated a clinical prognostic score in identifying trauma patients with, or at risk of, significant haemorrhage based on predicted probabilities of death due to bleeding: BATT score. This score was developed from an international cohort using data from 271 Trauma Centres in 41 countries on 5 continents and uses first clinical parameters at initial assessment. The BATT score predicts death due to bleeding and has been validated on a large population in England and Wales. It could also predict massive transfusion, as a surrogate of haemorrhagic death, earlier at the trauma scene. Its feasibility and external validation would make its clinical utility superior to other scores while identifying a greater number of patients requiring early management.

Our study is an external validation of pre-existing prognostic scores of traumatic haemorrhages (TASH , ABC and BATT score) at different times of care (Scene of Injury, admission at the trauma room) in order to assess their overall performance, discrimination and calibration in the prediction of massive transfusion, and haemorrhagic death. The objective of the study is to assess a comparison of score performances (Overall performance, discrimination and calibration).

Due to the study population (STR), which is partly integrated into the German DGU-Register, the investigators expect good transportability of the TASH score to the Swiss Trauma Registry in terms of overall performance, discrimination and calibration. The ABC score should show lowers results in terms of discrimination due to its validation on small cohorts exclusively in North America. The new BATT score predicting death due to bleeding has been validated on a large English cohort of more than 100,000 patients. It identifies all patients with haemorrhage and not only patients who have received a massive transfusion subject to survival bias. In this context, the BATT score provides good discrimination with only simple physiological variables available at the trauma scene. In case of its external validation on the STR as part of our study, its feasibility would make its clinical utility superior to other pre-existing scores, while identifying a greater number of patients requiring early management. Its application would activate a massive transfusion plan directly at the trauma scene and save precious time.

详细描述

1 Study Method

1.1 Study Design

The MTP STUDY is a retrospective, observational, non-interventional study based on a multicentric, anonymised Register. The Study is conducted by the emergency department of the University Hospital (CHUV) in Lausanne, Switzerland. The study design is observational, and no intervention is applied as part of the study protocol.

1.2 Sample Size and Power consideration

As his study is retrospective, the sample size is fixed. The number of participants will depend on the STR Database. The investigators anticipate using the data of 10'000 participants included in the Swiss Trauma Registry from 1st January 2015 to 31st December 2019. A post-hoc power calculation will be performed.

研究设计

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

入排标准

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

入选标准

  • Age > 16 years old
  • ISS ≥ 16 and/or AIS head ≥ 3

排除标准

  • Age < 16 years old
  • ISS < 16 and/or AIS head <3
  • Isolated Burns (including electric shock) or if the burn is clearly the primary injury
  • Patients arriving at the trauma room without signs of life and no diagnostic/therapeutic measures have been initiated for them
  • Choking or Hanging patient without any other injury
  • Drowning patients

结局指标

主要结局

Presence of Massive transfusion

时间窗: 24 hours after trauma

The primary outcome is the presence of massive transfusion (MT) in Swiss trauma patients, defined by a transfusion equal to or greater than 10 Red blood cell (RBC) in the first 24 hours or ≥ 3 RBC in the first hour if available in the Swiss Trauma Registry.

次要结局

  • Early death (< 24 hours)(24 hours after trauma)
  • Coagulopathy at Hospital admission(within 2 hours of hospital admission)
  • Death due to bleeding(at 28 days after trauma)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alan Costa

Principal Investigator

Centre Hospitalier Universitaire Vaudois

研究点 (1)

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