The Hemobag®a Novel Whole Blood Salvaging The Hemobag® a Novel Whole Blood Salvaging Technique and Device for Salvaging Blood from ECC’s Clinical Validation.

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The Hemobag®a Novel Whole Blood Salvaging The Hemobag® a Novel Whole Blood Salvaging Technique and Device for Salvaging Blood from ECC’s Clinical Validation Study Objectives: To determine the length of time to process and return blood from standard extracorporeal circuits and compare whole blood values from the patient at the separation of CPB, and in the Hemobag after processing the volume salvaged and hemoconcentrated. Methods: Twenty (20) post CPB patients circuits were salvaged and timed for recovery, and processing using a Hemobag & TS3 tubing set and conventional hemoconcentrators (Cobe, Minntech, Jostra, Capiox). Samples were drawn from the patients at the separation of CPB, and from the Hemobag after the conclusion of processing and compared. Results: The average length of time to fill the Hemobag from the Circuit by chasing the blood out of the circuit and into the Hemobag with crystalloid volume displacement was 90 sec +/- 20 sec. The average length time it took to hemoconcentrate the contents of the Hemobag, i.e., 2 Liters to the final volume was 9.5 min +/- 1 min for a Total time of 11 min +/- 80 sec. Average Volume returned to patient was 850mls +/- 150mls The average change in blood parameters were: Patient Post-Hemobag HCT 23.0 % 45.0 %, Fibrinogen 154 mg/dl 312 mg/dl, Platelet Concentration 114 K/ul 240 K/ul, Global Blood Resources LLC, P.O. Box 383 Somers, CT. USA The HEMOBAG Blood Salvage Device is a reservoir system that allows the patient’s whole blood to be Salvaged, Hemoconcentrated and Infused back to the same patient quickly, safely and efficiently in the same convenient reservoir bag ( Insuring ECC integrity ). A form of autologous whole blood management and conservation, it salvages anticoagulated whole blood from cardiopulmonary bypass circuits and other extracorporeal circuits using existing Ultrafiltration technology. The patented processing method concentrates the diluted anticoagulated whole blood within the closed circuit recovery loop of the tubing set by removing excess plasma water and low molecular weight solutes (including cytokines and anaphylatoxins) thereby reconcentrating the red cell mass and plasma proteins. The HEMOBAG’s TS3 Tubing Set doubles the use of any hemoconcentrator, allowing it to be used both during a procedure and/or after the procedure to salvage the autologous whole blood in the same or different circuit. Figure adapted with permission from: Farmer S, Webb D. Your Body, Your Choice: The layman's complete guide to bloodless medicine and surgery. Singapore: Media Masters: Boga M, Islamoglu, Badak I, et al. The effects of modified hemofiltration on inflammatory mediators and cardiac performance in coronary bypass surgery grafting. Perfusion, 2000; 15(2): Boldt J, Zickmann B, Czeke A, et al. Blood conservation techniques and platelet function in cardiac surgery. Anesthesiology, 1991; 75(3): Kiziltepe U, Uysalel A, Corapciolglu T, et al. Effects of combined conventional and modified ultrafiltration in adult patients. Ann Thoracic Surg. 2001; 71(2): Leyh RG, Bartels C, Joubert-Hubner E. et al. Influence of modified ultrafiltration on coagulation, fibrinolysis and blood loss in adult cardiac surgery. Euro J Cardiothoracic Surgery, 2001; 19(2): Luciani GB, Menon T, Vecchi B, et al. Modified ultrafiltration reduces morbidity after adult cardiac operations: a prospective, randomized clinical trial. Circulation, 2001; 104(12 Suppl 1): I Nakamura Y, Masuda M, Toshima Y, et al. Comparative study of cell saver and ultrafiltration nontransfusion in cardiac surgery. Ann Thorac Surg, 1990; 49(6): Tanemoto K, Hamanaka S, Morita I, Masaki H. Platelet activity of residual blood remaining in the Cardiopulmonary bypass circuit after cardiac surgery. J Cardiovasc Surg (Torino) Feb;45(1): Guo XY, Duan H, Wang JJ, Luo AL, Ye TH, Huang YG, et al. Effect of intraoperative cell saver use on blood sparing and its impact on coagulation function. Zhongguo Yi Xue Ke Xue Yuan Xue Bao 2004 Apr;26(2): Sedrakyan A, Gondek K, Paltiel D, Elefteriades JA. Volume expansion with albumin decreases mortality after coronary artery bypass graft surgery. Chest 2003 Jun;123(6): Infusion port Outlet port Inlet port Transfusion port Baffle Background and introduction. The benefits of Ultrafiltration are numerous: Saving the patient’s own platelets, clotting factors and plasma proteins especially albumin. Creates a hyperoncotic whole blood product with reduced cytokines and anaphylatoxins. Improves hematocrit and plasma proteins, and may improve the hemodynamics, pulmonary functions and hemostasis all within a matter of minutes of using any extracorporeal circuit. Efficiently salvages the patients Own autologous whole blood quickly while ensuring that the extracorporeal circuit remains primed and ready to go back on in an emergency. Conclusion: The Hemobag offers a new way to Manage and Salvage Autologous Whole Blood, and may offer advantages over the current technology of salvaging blood from extracorporeal circuits while improving patient outcomes. Current directions FDA approved, used throughout the USA. Clinical studies of efficacy of the end product. Hemodynamic, Pulmonary and Coagulation benefits. Transfusion reduction and avoidance. Data courtesy of Salem Hospital, Salem Oregon. Below is a summary of an Extracorporeal Circuit (ECC) Hemobag Whole Blood “Recovery Loop” See Graphs References : QUICK VOLUME LINE FOR ANESTHESIA TS3 Tubing Set “Standard Loop”