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

Not Applicable

Completed

Conditions: Spinal Surgery

Interventions: Device: Sangvia

Registration Number: NCT01251042

Lead Sponsor: Wellspect HealthCare

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 51

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sangvia and retransfusion	Sangvia	-
Sangvia and no retransfusion	Sangvia	-

Primary Outcome Measures

Name	Time	Method
Difference in Plasma Free Hemoglobin (p-Hb) Concentration	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

Secondary Outcome Measures

Name	Time	Method
Potassium Concentration	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)	Systemic potassium concentration from screening until 96 hours after surgery.
Plasma Free Hemoglobin (p-Hb) Concentration	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)	Systemic plasma free hemoglobin (p-Hb) concentration from screening until 96 hours after surgery.
Interleukin-6 (IL-6) Concentration	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)	Systemic IL-6 concentration from screening until 96 hours after surgery.
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)	Systemic hemoglobin concentration from screening until 96 hours after surgery.
Creatinine Concentration	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)	Systemic creatinine concentration from screening until 96 hours after surgery.
Mean Blood Loss Volume	After surgery (surgery takes place 1-7 days after screening)	Estimated blood loss during and after surgery.
Interleukin-1-alpha (IL-1-α) Concentration	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)	Systemic IL-1-α concentration from screening until 96 hours after surgery.
Interleukin-8 (IL-8) Concentration	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)	Systemic IL-8 concentration from screening until 96 hours after surgery.
Interleukin-10 (IL-10) Concentration	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)	Systemic IL-10 concentration from screening until 96 hours after surgery.
Tumor Necrosis Factor Alpha (TNF-α) Concentration	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)	Systemic TNF-α concentration from screening until 96 hours after surgery.
Interferon Gamma (IFN-γ) Concentration	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)	Systemic IFN-γ concentration from screening until 96 hours after surgery.