NCT00839241已完成不适用
An Open , Prospective, Randomized, Parallel Group Study to Investigate Whether Postoperatively Collected and Transfused Autologous Whole Blood Improves the Immunological Status in Comparison to Allogenic Blood Transfusion in Patients Undergoing Total Knee Replacement
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
- 45
- 试验地点
- 1
- 主要终点
- Frequency of Natural Killer Cells as Measured With Flow Cytometry.
研究概览
简要总结
The primary objective of the study is to compare the immunological status after either autologous blood transfusion as administered by Bellovac® ABT or allogenic blood transfusion, with regards to change in Natural Killer (NK) cell frequency in patients undergoing total knee replacement.
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
- 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
- •Provision of informed consent
- •Male and female patients aged 18 years and over scheduled for total knee replacement
- •Subjects 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)
- •Pre-operatively haemoglobin below normal range as judged by the investigator
- •Previous enrolment or randomisation to treatment in the present study
- •Expected or confirmed participation in another clinical study during the study period
- •Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
- •Current symptoms of haemophilia
- •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) as deemed by investigator
- •Use of pre-donation
- •Use of recombinant erythropoetin
- •Use of other autologous blood transfusion than that with Bellovac ABT, e.g. washed and centrifuged blood like CellSaver
研究组 & 干预措施
Autologous Blood Transfusion
Experimental
干预措施: Bellovac ABT (Device)
Allogenic Blood Transfusion
Active Comparator
干预措施: Allogenic Blood Transfusion (Procedure)
结局指标
主要结局
Frequency of Natural Killer Cells as Measured With Flow Cytometry.
时间窗: Day 8 postop
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)
时间窗: Day 8 postop
Frequency of Natural Killer Cells as Measured With Flow Cytometry.
时间窗: Baseline
Frequency of Natural Killer Cells as Measured With Flow Cytometry.
时间窗: Day 5 postop
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)
时间窗: Baseline
Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)
时间窗: Day 5 postop
次要结局
- Erythrocyte Volume Fraction(Day 8 postop)
- Lymphocytes(Day 8 postop)
- Interleukin-6(Day 8 postop)
- Interleukin-2(Day 8 postop)
- Leucocyte Particle Concentration(Day 8 postop)
- Interleukin-4(Day 8 postop)
- Interleukin-10(Day 8 postop)
- TNF-Alpha(Day 8 postop)
- Hemoglobin(Day 8 postop)
- Interferon Gamma(Day 8 postop)
- Lymphocytes(Day 1 postop)
- Lymphocytes(Day 5 postop)
- Interferon Gamma(Baseline)
- Interferon Gamma(Day 5 postop)
- Interleukin-2(Baseline)
- Interleukin-2(Day 5 postop)
- Interleukin-4(Baseline)
- Interleukin-4(Day 5 postop)
- Interleukin-6(Baseline)
- Interleukin-6(Day 5 postop)
- Interleukin-10(Baseline)
- Interleukin-10(Day 5 postop)
- TNF-Alpha(Baseline)
- TNF-Alpha(Day 5 postop)
- Hemoglobin(Baseline)
- Hemoglobin(Day 1 postop)
- Hemoglobin(Day 5 postop)
- Erythrocyte Volume Fraction(Baseline)
- Erythrocyte Volume Fraction(Day 1 postop)
- Erythrocyte Volume Fraction(Day 5 postop)
- Leucocyte Particle Concentration(Baseline)
- Leucocyte Particle Concentration(Day 1 postop)
- Leucocyte Particle Concentration(Day 5 postop)
- Lymphocytes(Baseline)
研究者
研究点 (1)
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