Leukocyte Depletion of Autologous Whole Blood: Impact on Perioperative Infection Rate and Length of Hospital Stay for Hip Arthroplasty Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,089
- 试验地点
- 6
- 主要终点
- Comparison of infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay
研究概览
简要总结
Leukocyte depletion of autologous whole blood prior to storage does not reduce infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay but may increase retransfusion perioperatively during hip arthroplasty and allogenic transfusion rate
详细描述
Informed Consent Form:
Prior to the first blood donation, in- and exclusion criteria should be tested. Then the patient is to inform by the investigator about the studies aim and participation conditions such as methods, risks, assurance, data security, etc. The patient and the investigator should sign the informed consent form.
Randomization:
If all inclusion criteria are well given and exclusion criteria are absent, the patient could be enrolled and randomized, prior to the first PAD. Enrollment is parallel in all centers until the final number of 1088 is reached. Breaking the seal of the provided randomization envelope with computerized randomization codes completes randomization. Time and date should be noted.
Blinding:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• ASA I-III,
- •Age 18-85 years,
- •Body weight 50-125 kg
- •If female, with either a history of an accepted method of anticonception for at least 3 month prior and 1 month following the termination of the study or climacteric or with a negative betA- HCG-Test in urine or serum.
- •Preoperative blood donation of at least 2 units (450mL whole blood)
- •Preoperative hemoglobin level > 10 mg/dL
- •Able and willing to sign informed consent
排除标准
- •Subjects with a contraindication for preoperative blood donation (PAD) (in 12, PP 36-43).
- •systemic infection
- •acute bacterial or viral diseases
- •anemia (Hb > 11g/dL)
- •myocardial infarction within the past 6 month,
- •instable angina pectoris
- •vascular stenosis (i.e. of the coronary or internal carotid arteries)
- •hemodynamic relevant valvular stenosis
- •heart failure > NYHA II
- •history of strokes or TIA
- •steroid therapy,
- •immune deficiency,
- •hematological or endocrinological disease,
- •coagulopathy,
- •history of organ transplantation,
- •simultaneous participation in a second study
- •pregnancy
- •membership at Jehovah's Witnesses
- •intended use of a cell saver
结局指标
主要结局
Comparison of infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay
时间窗: 90 days
次要结局
- Blood loss and transfusion rate(90 days)