Cost Effectiveness and Clinical Utility of Cell Saver Use for Two to Three Level Lumbar Fusions

INTRODUCTION:

Cell Savers are used intraoperatively to decrease the risk of transfusion due to surgical blood loss. Blood collected from the operative field is anticoagulated, filtered, and stored in a reservoir. Once a set volume of blood has been collected in the reservoir, the blood is separated into its red blood cell and plasma components by use of a centrifuge. Red blood cells are washed with a crystalloid solution and then reinfused into the patient. Although the theoretical benefits of using a cell saver are attractive, the literature seems to be controversial with respect to efficacy and cost-effectiveness. The benefits are clear in patients undergoing fusions for scoliosis that involve more than 5 levels where blood loss is considered substantial. It is less clear in patients who undergo a more limited two to three level lumbar fusion.

The purpose of this study is to determine the cost-effectiveness of using a cell saver for 2 to 3 level lumbar fusions. A secondary objective is to determine if there will be a decrease in the number of allogenic blood transfusions when a cell saver is used intraoperatively. Another secondary objective is to determine incidence of complications associated with cell saver use and transfusions.

METHODS Patients seen at the Norton Leatherman Spine Center scheduled to have decompression and fusion over 2 to 3 lumbar spine segments will be screened for the study. After obtaining informed consent, patients will be randomized to have a cell saver used intraoperatively (Cell Saver group) or no cell saver (Non-Cell Saver group). Data to be collected will include age, gender, smoking status, height, weight, co-morbidities, the use of medications that may increase bleeding (Plavix, Coumadin, Warfarin), or increase blood production (Ferrous sulfate, erythropoietin) medications used to decrease intraoperative bleeding (Aprotinin, Tranexamic Acid); the use of hypotensive anesthesia, ASA Grade, indications for surgery, date of surgery, estimated blood loss, surgical approach, surgical levels, bone graft used, operative time, complications, length of stay, discharge information, whether or not patient pre-donated blood, hemoglobin, hematocrit and maximum body temperature prior to surgery and during the patient's hospital stay, surgical drain output, products transfused intraoperatively and postoperatively and the amount of cell saver salvaged, re-infused, and the cell-saver hematocrit and hemoglobin prior to re-infusion. The costs associated with the use of the cell-saver and/or blood transfusions, including supplies and personnel time, will be determined.

Randomization Randomization will be through stratified block randomization to allow for stratification of the number of levels fused. Randomization will use sealed envelopes.