Use of Blood and Plasma in Prehospital Haemorrhagic Shock - a Prospective, Observational Trial of Advanced Deployment of Blood Products in Norwegian Physician-staffed Helicopter Emergency Medical System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 9
- 主要终点
- adverse transfusion reactions
研究概览
简要总结
The main objective of this study is to evaluate the use of RBC, FDP, WB in the treatment of exsanguinating patients by physician-staffed emergency medical services in Norway, with focus on prehospital transfusion complications and safety.
详细描述
This study evaluates prehospital transfusion therapy in exsanguinating patients treated by physician-staffed emergency medical services in Norway, with the following main questions:
I. Are out-of-hospital transfusions associated with an increase in adverse transfusion events compared to inhospital transfusions?
II. Is out-of-hospital physician administration of plasma or blood products in exsanguinating patients feasible?
III. Are patients in need of blood product transfusion possible to identify and transfuse in the prehospital phase/environment?
IV. Are out-of-hospital transfusion practices associated with increased waste of blood products?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products according to listed indicators below:
- •Patients with mechanism of injury compatible with severe haemorrhage and/or haemorrhagic shock (e.g. penetrating torso injury, visible massive bleeding)
- •Radial pulse > 100 beats/min or absent/weak radial pulse
- •Systolic blood pressure (SBP) < 90 mmHg
- •Altered mental status (reduced GCS) in the absence of head injury or known intoxication
排除标准
- •Patients with known previous serious allergic reactions to blood product transfusions
- •Patients who refuse blood products on religious grounds, e.g. Jehovah´s Witness
研究组 & 干预措施
Single group
Patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products, either red blood cells (RBC), freeze dried plasma (FDP) or whole blood (WB).
干预措施: Red blood cells (0Rh D-neg) (Drug)
Single group
Patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products, either red blood cells (RBC), freeze dried plasma (FDP) or whole blood (WB).
干预措施: Whole blood (O Rh D-neg K-neg) (Drug)
Single group
Patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products, either red blood cells (RBC), freeze dried plasma (FDP) or whole blood (WB).
干预措施: Freeze dried plasma (LyoPlas) (Drug)
结局指标
主要结局
adverse transfusion reactions
时间窗: 24 hours
Fraction of patients with suspected adverse transfusion reactions after administration of plasma and/or blood products.
patients included
时间窗: 24 hours
Fraction of patients fulfilling inclusion criteria with prehospital administration of blood products
units not used
时间窗: 24 hours
Fraction of prepared plasma or blood units not used.
次要结局
- Type of adverse events(24 hours)
- Systolic blood pressure (SBP)(24 hours)
- on-scene time (minutes)(24 hours)
- Glasgow Coma Score (GCS)(24 hours)
- Pulse oximeter (SPO2)(24 hours)
- response time (minutes)(24 hours)
- transport time (minutes)(24 hours)
- Number of surgical interventions(24 hours)
- number of transfusion(24 hours)
- heart rate (HR)(24 hours)
- Number of adverse events(24 hours)
- type of transfusion(24 hours)
- Respiratory rate (RR)(24 hours)
- Type of surgical interventions(24 hours)