A Prospective, Randomized, Controlled Study on Intra-operative Autologous Transfusion With the Sangvia® Blood Salvage System in Spinal Surgery
- 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.
- 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.
- 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.
- 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
- Hypotensive anesthesia.
- Use of antithrombotic medication within 5 days of surgery (NSAID, Clopidogrel).