European Transfusion Practice and Outcome Study A Multi-central Evaluation of Standard of Transfusion Care and Clinical Outcome for Elective Surgical Patients. Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,066
- 试验地点
- 9
- 主要终点
- Amount of PRBC and blood products and coagulation factors transfused
研究概览
简要总结
The aim of the ETPOS study is to describe differences in transfusion habits throughout Europe and to correlate these habits to perioperative outcome parameters. Special focus is put on the number of PRBCs (packed red blood cells) transfused and the ratio of PRBCs to other blood products or coagulation factors in the operating room. Furthermore the motivation of physicians to transfuse PRBC and blood products in the operating room will be investigated.
详细描述
In European patients undergoing elective non-cardiac surgery receiving at least one PRBC(packed red blood cells) during their surgery it is proposed to:
-
Evaluate evidence of differences in the standard of peri-operative transfusion care in different healthcare systems within Europe, and the use of blood conserving techniques.
-
Evaluate the ratio of transfusion of PRBC to blood products in the operating room
-
Evaluate which factors determine transfusion of PRBC (is it patient's haemodynamics / haemoglobin threshold/ pressure from the surgeon / acute brisk bleeding / else) and blood products (ratio to PRBC / POC (point of care) monitoring/ per protocol/ else) in the operating room
-
Evaluate whether there are factors in transfusion therapy that are associated with outcome (in-hospital mortality and unplanned admission to ICU(Intensive Care Unit).)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing elective non-cardiac surgery commencing during the three-month period and who received at least one erythrocyte concentrate during their intra-operative stay.
排除标准
- •Age < 18 years
- •cardiothoracic surgery
- •emergency trauma patients
结局指标
主要结局
Amount of PRBC and blood products and coagulation factors transfused
时间窗: The Time point at which outcome measure is assessed is during surgery at Day 0
Amount of packed red blood cells and blood products and coagulation factors: fresh frozen plasmas (FFPs), platelets (PTs) and tranexamic acid transfused
次要结局
- Factors determining transfusion of PRBC and blood products in different regions of Europe(The Time point at which outcome measure is assessed is during surgery at Day 0)
- 30-day mortality(The Time point at which outcome measure is assessed is at Day 30 after Surgery)
- Type and frequency of usage of blood conserving techniques(The Time point at which outcome measure is assessed is at Day 0, on Surgery Day)
- Unplanned admission to the ICU(The Time point at which outcome measure is assessed is at Day 30 after Surgery)