Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood

Inclusion criteria

• 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.

Exclusion criteria

• 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).