Clinical Trial: Evaluation of 2 Different Protocols of Blood Derivates Transfusion in Acute Trauma Patients in a Brazilian Tertiary Hospital
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 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:
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- Fresh Frozen Plasma, Platelets Concentrate and Packed red blood cells in 1:1:1 ratio.
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- 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:
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- Trauma victims
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- Adults between 18 - 80 years old
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- Injury Severity Score (ISS) between 15 and 45
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- Assessment of Blood Consumption (ABC) Score ≥ 3 points
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- Shock Index ≥ 1,2
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- 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. -
研究组 & 干预措施
Blood Products only.
This arm will receive 1:1:1 Red blood cells : Fresh Frozen Plasma : Platelets upon a major trauma triggers. 1:1:1 Ratio for packs of blood products. The patient will be re-evaluated every hour again for the major bleeding triggers and another 1:1:1 intervention may or may not occur.
干预措施: Blood Products only (Other)
Point of care guided
This arm will receive Red blood cells, Human Fibrinogen and Prothrombinic complex concentrates (PCC) based on thromboelastometry. The dosis of each drug will be determined by the analyses of the thromboelastometry curves.
干预措施: Point of Care guided (Other)
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