NCT02020525已完成不适用
The Impact of Lowering Transfusion Trigger on Patient Immune Response During Major Abdominal Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- The number of units transfused per patient as well as the incidence of blood transfusions in each transfusion strategy group (restrictive versus liberal)
研究概览
简要总结
- We have previously reported the results of the primary and secondary outcomes of a randomized study aiming to investigate the impact of a restrictive transfusion protocol on the magnitude of reduction in blood transfusion in a typically mixed general surgery population subjected to major abdominal surgery.
- The main finding of that study was a reduction in red blood cell usage with the implementation of a restrictive transfusion regimen. This was achieved without adversely affecting clinical outcome in the population studied.
- The aim of this secondary analysis performed on a subgroup of 20 patients from the original study was to determine whether there are any differences in the postoperative immunologic response, as expressed by the production of inflammatory mediators, between a restrictive approach to red cell transfusion and a more liberal strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
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
- •Adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective upper major abdominal surgery
排除标准
- •history of bleeding diathesis
- •hereditary hemostatic defects such as hemophilias
- •chronic anticoagulant administration
- •refusal of transfusions for religious reasons
- •ischemic heart disease (unstable angina or myocardial infarction within the last six months)
- •preexisting infectious diseases
- •preexisting autoimmune diseases
- •use of corticosteroids or immunosuppressive drugs within the last six months
研究组 & 干预措施
restrictive transfusion strategy
Experimental
Patients allocated to the restrictive transfusion strategy were transfused only when their hemoglobin concentration decreased below 7.7 g d dL-1 and were then maintained at hemoglobin concentrations between 7.7 and 9.9 g d dL-1.
干预措施: restrictive transfusion strategy (Procedure)
liberal transfusion strategy
Active Comparator
Patients assigned to the liberal strategy were transfused when their hemoglobin concentration fell below 9.9 g dL-1, aiming at maintaining hemoglobin at or above 10 g dL-1.
干预措施: liberal transfusion strategy (Procedure)
结局指标
主要结局
The number of units transfused per patient as well as the incidence of blood transfusions in each transfusion strategy group (restrictive versus liberal)
时间窗: first five postoperative days
次要结局
- time of initial mobilization postoperatively(first five postoperative days)
- time of first liquid food intake(first five postoperative days)
- time of first solid food intake(first five postoperative days)
- incidence of postoperative infectious complications(first five postoperative days)
研究者
Dr Kassiani Theodoraki
Associate Professor in Anesthesiology
Aretaieion University Hospital
研究点 (2)
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