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临床试验/NCT04410952
NCT04410952已完成不适用

Bleeding Control in Type-C Pelvic Ring Fractures Using the Pelvic C-clamp vs. the Pelvic Binder for Emergency Stabilization - a Matched Pair Analysis From the German Pelvic Registry

BG Trauma Center Tuebingen1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月7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
120
试验地点
1
主要终点
Need for transfusion

研究概览

简要总结

Pelvic ring fractures carry a high risk for severe bleeding. Expecially bleeding from the posterior ring might result in a fatal course. Different types of external emergency stabilization (EES) are available for the posterior pelvic ring, namely the non-invasive pelvic binder or the invasive pelvic c-clamp. Which stabilization technique is superior, has not been investigated yet.

详细描述

Severe bleeding is the major cause of death in unstable pelvic ring fractures. Therefore, a quick and efficient emergency stabilization and bleeding control is inevitable. The pelvic C-clamp and the pelvic binder are efficient tools for temporary bleeding control, especially for the posterior pelvic ring. However, whether these disadvantages make up for a more efficient bleeding control, still needs to be discussed in the guidelines of the emergency management of pelvic ring fractures.

Patients with a type-C pelvic ring fracture were identified from the German Pelvic Registry (GPR). The patients were divided into three groups of 40 patients: 1. group without emergency stabilization, 2. group treated with pelvic binder and 3. group treated with pelvic C-clamp. The patients were matched according to the following parameters: age, gender, initial RR and HB level. The complication rates and mortality rates were compared between the groups, especially regarding bleeding control, as measured by the amount of transfused blood products. Furthermore, the subjective efficacy of the treatment was assessed. Finally, the time until established bleeding control was compared.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent for data acquisition in the German Pelvic Registry
  • Pelvic ring fracture Type C (AO/OTA)
  • ISS (Abdomen) >8

排除标准

  • Acetabular fracture
  • Pelvic ring fracture Type A/B (AO/OTA)
  • ISS (Abdomen) <9

结局指标

主要结局

Need for transfusion

时间窗: 24 hours

Number of transfused units of packed red blood cells

Time until emergency stabilization

时间窗: 6 hours

The time until emergency stabilization device is placed in minutes

次要结局

  • Mortality rate(6 months)
  • Complication rate(6 months)
  • Length of hospital stay(6 months)

研究者

发起方
BG Trauma Center Tuebingen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Markus Küper

PD Dr. med.

BG Trauma Center Tuebingen

研究点 (1)

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