A Prospective, Randomized, Controlled Study on Intra-operative Autologous Transfusion With the Sangvia® Blood Salvage System in Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Difference in Plasma Free Hemoglobin (p-Hb) Concentration
研究概览
简要总结
The study is an open, randomized, controlled, single-centre study including a total of 42 evaluable subjects scheduled for spinal surgery with an approximate expected bleeding of 800-1500 ml. The Sangvia® Blood Salvage System will be set up for all subjects to collect blood intra-operatively. When the transfusion bag is filled, i.e. when around 500 ml of blood has been collected, the subject will be randomized to either be retransfused with the blood collected (investigational group) or not (control group). The primary objective for this study is to investigate the blood quality and isolate the systemic effects in intra-operatively collected blood. The systemic p-Hb concentration has been chosen as the primary outcome variable based on previous experience and literature and is considered as the major safety concern for the study subjects.
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 subjects aged 18 years and over subjected to spinal surgery with an approximate expected bleeding of 800-1500 ml.
- •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).
- •Previous enrolment or randomisation of treatment in the present study.
- •Participation in another clinical study, that may interfere with the present study.
- •Severe non-compliance to protocol as judged by the investigator and/or Astra Tech.
- •Haemophilia.
- •Hyperkalemia (i.e. values above the normal reference values at study site).
- •Symptoms of impaired renal function including creatinine clearance levels (using the Cockcroft-Gault formula) <30 ml/min.
- •Malignancy in the area of the operative site.
- •Current or expected use of cytotoxic drugs.
- •Symptoms of systemic infection or local infection in the operation field.
- •Pregnancy.
- •Sickle cell anaemia and/or pre-operative Hb concentration <11 g/dl (6,8 mmol/l).
- •Use of recombinant erythropoietin (EPO) or fibrin sealant.
- •Use of other autologous blood transfusion than with the Sangvia® system (e.g. CellSaver and pre-donation) or other blood saving techniques (e.g. normovolemic hemodilution).
- •Hypotensive anesthesia.
- •Use of antithrombotic medication within 5 days of surgery (NSAID, Clopidogrel).
结局指标
主要结局
Difference in Plasma Free Hemoglobin (p-Hb) Concentration
时间窗: At screening and 24 hours after surgery (surgery takes place 1-7 days after screening)
Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery
次要结局
- Potassium Concentration(At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening))
- Plasma Free Hemoglobin (p-Hb) Concentration(At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening))
- Interleukin-6 (IL-6) Concentration(At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening))
- Frequency of Allogenic Blood Transfusion(Up until 96 hours after surgery (surgery takes place 1-7 days after screening))
- Hemoglobin Concentration(At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening))
- Creatinine Concentration(At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening))
- Mean Blood Loss Volume(After surgery (surgery takes place 1-7 days after screening))
- Interleukin-1-alpha (IL-1-α) Concentration(At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening))
- Interleukin-8 (IL-8) Concentration(At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening))
- Interleukin-10 (IL-10) Concentration(At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening))
- Tumor Necrosis Factor Alpha (TNF-α) Concentration(At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening))
- Interferon Gamma (IFN-γ) Concentration(At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening))