A Prospective, Randomized, Controlled Trial of Retransfusion of Intra-operatively Collected Filtered Whole Blood in Total Hip Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 12
- 主要终点
- Number of Participants in Need for Bank Blood Transfusion
研究概览
简要总结
The study is a prospective, controlled, randomised and assessor blind study that investigate if the need for bank blood transfusion could be reduced in patients, undergoing primary or revision total hip replacement surgery, who receive their own blood back with the medical device Sangvia.
A comparison in need for bank blood will be made between patients that either receive their own blood back or not.
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
- Single (Outcomes Assessor)
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
- •Provision of informed consent
- •Scheduled for primary or secondary, cemented or non-cemented, total hip arthroplasty
- •Classified as ASA Physical Status Classification System class P1, P2 or P3 according to the American Society of Anaesthesiology.
排除标准
- •Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
- •Previous enrollment or randomisation of treatment in the present study
- •Expected or confirmed participation in another clinical study, that may interfere with the present study, during the study period
- •Suspected severe non-compliance to protocol as judged by the investigator
- •Current symptoms of haemophilia
- •Current symptoms of hyperkalaemia
- •Current symptoms of systemic infection or local infection in the operation field
- •Current symptoms of impaired renal function including creatinine/clearance levels above the normal reference values
- •History of or presence of malignant disease with propensity for systemic spread during the last 5 years
- •Current or expected use of cytotoxic drugs
- •Current untreated anaemia (e.g. sickle cell anaemia), i.e. Hb concentration < 11 g/dl (7 mmol/l)
- •Use of recombinant erythopoetin
- •Use of aprotinin and/or fibrin sealant
- •Use of other autologous blood transfusion than that with the Sangvia® system (e.g. CellSaver, pre-donation, acute normovolemic haemodilution etc.)
- •Women of childbearing age
- •Fractures
- •Revision/secondary total hip surgery with expected serious bone grafting
结局指标
主要结局
Number of Participants in Need for Bank Blood Transfusion
时间窗: At discharge
Bank blood transfusions were given in both groups after assessment of independent assessor, by using a transfusion trigger. All transfusions were recorded in a transfusion log and summarized at discharge. The total number of patients per group in need for any bank blood transfusion was compared. The participant were followed for the duration of hospital stay, an average of 6 days (SD 3 days)
次要结局
未报告次要终点