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临床试验/NCT04764864
NCT04764864撤回不适用

Randomized Multicenter Study on the Management of Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing

Nuria Llorach-Perucho2 个研究点 分布在 1 个国家开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Pelvic bleeding control based on clinical response

研究概览

简要总结

Pelvic fracture is a usual injury in trauma patients. An unstable trauma patient with a pelvic fracture has an elevated risk of death due to pelvic bleeding and the associated injuries. Traditionally, it has been estimated that the main source of bleeding is venous and, consequently, the main treatment has been the preperitoneal pelvic packing. Nevertheless, according to new data, arterial bleeding appears to be a more important source of pelvic bleeding than it was thought and angioembolization seems to be a good alternative in the treatment of these injuries. Consequently, it is important to define better the management of these patients.

This investigation project consists in a clinical trial study, performed by a multidisciplinary team of many hospitals around the country, in which angioembolization and preperitoneal pelvic packing are compared. Unstable trauma patients with a pelvic fracture and no other injuries (negative FAST / peritoneal aspiration, no evidence of bone fractures or thoracic injuries) will be submitted, in less than 60 minutes from hospital arrival, to angioembolization or preperitoneal pelvic packing, according to randomization. There will be a specific timing evaluation of different markers: hemodynamic (vital signs at arrival, immediately and 24 hours after treatment) and analytic (at arrival and upon entering to the Intensive Care Unit). Registered variables include: blood cell transfusions, vasoactive drug requirements, time elapsed between hospital admission and intervention, treatment duration, need of other strategies to stop pelvic bleeding, complications and mortality.

The objective of this study is to determinate if angioembolization is superior to preperitoneal pelvic packing for pelvic bleeding control in unstable trauma patients due to pelvic bleeding.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Systolic blood pressure ≤ 90 mmHg
  • Heart rate > 100 bpm
  • Shock Index ≥ 0,8
  • Pelvic fracture
  • Negative FAST / peritoneal aspiration

排除标准

  • Other causes of bleeding that require treatment

结局指标

主要结局

Pelvic bleeding control based on clinical response

时间窗: 24 hours

Clinical response after the intervention

次要结局

  • Additional techniques(Through study completion, an average of 2 years)
  • Post-procedure complications(Through study completion, an average of 2 years)
  • Blood cell transfusion(Through study completion, an average of 2 years)
  • Time until intervention(Time until intervention (up to 60 minutes))
  • Mortality(Through study completion, an average of 2 years)
  • Post-procedure complications degree(Through study completion, an average of 2 years)

研究者

发起方
Nuria Llorach-Perucho
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nuria Llorach-Perucho

Principal Investigator

Corporacion Parc Tauli

研究点 (2)

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