Optimal Blood Management in Elective Orthopaedic Surgery: The Transfusion "Op Maat" (TOMaat) Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,598
- 试验地点
- 4
- 主要终点
- Number of allogeneic red blood cell (RBC) transfusions.
研究概览
简要总结
Aim: to investigate whether the use of several transfusion alternatives (erythropoietin, the cell-saver or postoperative drainage and reinfusion systems) in patients undergoing elective total knee or hip replacement surgery can lead to allogeneic red blood cell (RBC) saving if a restrictive transfusion policy is used.
Study design: a prospective, double randomized, open, multicenter study in which patients are stratified according to their preoperative hemoglobin(Hb) level: stratum I= Hb between 6,1 and 8,2 mmol/l. These patients are first randomized for Erythropoetin (Epo) or no Epo.
Stratum II= Hb of 6,1 and lower or 8,2 mmol/l and higher, are not eligible for Epo and thus not randomized. Patients in both strata will be randomized for three modalities: a cell saver (CS)(to wash, filter and reinfuse autologous shed blood) which is used intra- and postoperatively or a postoperative autologous reinfusion drainage system (D) only (to filter and reinfuse autologous shed blood) or a restrictive transfusion trigger only (controls).
Inclusion criteria: All orthopedic patients of 18 years and older being considered for a primary or revision total knee- (TKR) or total hip replacement (THR).
Outcome measures:
Primary outcome: number of allogeneic red blood cell (RBC) transfusions.
Secondary outcome: transfusion reactions, rehabilitation time, length of hospital stay (days), peri- and post-operative complications during hospitalization, quality of life, cost analysis
详细描述
Power/data analysis: In order to be able to detect a 75% reduction of allogeneic transfusions by Epo and a reduction of 30% by autologous (shed blood) transfusions (CS or D) with a power= 0.9 and an alpha= 0.05, inclusion of 2250 surgery patients (in a worst case scenario of high standard deviations) are required for intention-to-treat analysis.
Knee surgery patients are not randomized for cell saver (no intra-operative blood loss).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Orthopaedic patients of 18 years and older being scheduled for a primary or revision total knee (TKR) or total hip replacement (THR).
排除标准
- •Patients who refuse homologous blood (e.g.Jehovah's witnesses),
- •Patients with untreated hypertension (diastolic blood pressure > 95 mm Hg),
- •Patients with a serious disorder of the coronary artery, peripheral arteries and/or carotid arteries,
- •A recent myocardial infarction or CVA,
- •Sickle cell anaemia patients,
- •Malignancy in the operated area,
- •Pregnancy,
- •Unsuitability for peri-operative anticoagulation prophylaxis,
- •Known allergy to erythropoietin,
- •An infected wound bed,
- •Revision of an infected prosthesis which is being treated with antibiotics, OR
- •Patients with difficulty understanding the Dutch language (unable to give informed consent or patients who insufficiently control the Dutch language).
研究组 & 干预措施
Erythropoietin
干预措施: erythropoietin (Drug)
cell saver
干预措施: OrthoPAT (Device)
drain
干预措施: Post-operative drain device (Device)
Erythropoietin and cell saver
干预措施: erythropoietin and cell saver (Other)
Erythropoietin and cell saver
干预措施: Erythropoietin and OrthoPAT (Other)
Erythropoietin and drain
干预措施: Erythropoietin and drain device (Other)
结局指标
主要结局
Number of allogeneic red blood cell (RBC) transfusions.
时间窗: up to 3 months after surgery
次要结局
- Harris hip / knee society score (for determination of the mobility of the operated joint)(pre-operative and after 3 months)
- Cost analysis(up to 3 months after surgery)
- Length of hospital stay(In hospital)
- Peri- and post-operative complications during hospitalization(up to 3 months after surgery)
- Rehabilitation time(in hospital)
- Hb/Ht post-operative(at 14 days and 3 months after surgery)
- Quality of life(Up to 3 months after surgery)
- Transfusion reactions(up to 3 months after surgery)