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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Controlled Study on Intra-operative Autologous Transfusion With the Sangvia® Blood Salvage System in Spinal Surgery

Conditions
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Spinal Surgery

Intervention / Treatment
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* Device: Sangvia


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sangvia and retransfusion<br> | Device: Sangvia<br>* The Sangvia® Blood Salvage System used to collect blood intra-operatively.<br>|
| Sham Comparator: Sangvia and no retransfusion<br> | Device: Sangvia<br>* The Sangvia® Blood Salvage System used to collect blood intra-operatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Plasma Free Hemoglobin (p-Hb) Concentration | Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery | At screening and 24 hours after surgery (surgery takes place 1-7 days after screening) | 

Secondary Outcome Measures

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