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临床试验/NCT02416817
NCT02416817已完成4 期

Clinical Trial: Evaluation of 2 Different Protocols of Blood Derivates Transfusion in Acute Trauma Patients in a Brazilian Tertiary Hospital

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
156
试验地点
2
主要终点
SOFA Score - 5 days

研究概览

简要总结

The purpose of this study is to compare two already validated methods for massive transfusion in trauma patients admitted to the emergency room of a large reference hospital.

详细描述

In this randomized trial trauma patients in need of massive transfusion will be assigned to one of the following transfusion strategies:

    • Fresh Frozen Plasma, Platelets Concentrate and Packed red blood cells in 1:1:1 ratio.
    • These patients will receive Red blood cells based on Haemoglobin measurements and will receive either Beriplex® P/N (CSL Behring GmbH, Marburg, Germany) or Haemocomplettan® P (CSL Behring, Marburg, Germany), or Platelets based on thromboelastometry.

To be included patients must meet the following inclusion criteria:

    • Trauma victims
    • Adults between 18 - 80 years old
    • Injury Severity Score (ISS) between 15 and 45
    • Assessment of Blood Consumption (ABC) Score ≥ 3 points
    • Shock Index ≥ 1,2
    • Acute hemorrhage of more than 50% estimated blood volume in 3 hours or more than 1,5 ml/kg/min of blood during 20 minutes.

Exclusion Criteria:

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Trauma victims
  • Adults between 18 - 80 years old
  • Injury Severity Score (ISS) between 15 and 45
  • Assessment of Blood Consumption (ABC) Score ≥ 3 points
  • Shock Index ≥ 1,2

排除标准

  • Early cardiac arrest
  • Pregnancy
  • ISS > 45
  • Patient transferred from another hospital
  • Drug abuse history
  • Known coagulation impairment
  • Known use of anticoagulants, or platelet anti-aggregants. -

结局指标

主要结局

SOFA Score - 5 days

时间窗: 5 days

Evaluation of the SOFA score along the first 5 days after the patient admission.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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