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
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
- 否
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
研究点 (2)
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