A novel autotransfusion device saving erythrocytes and platelets used in a 72 h survival swine model of surgically induced controlled blood loss

Abstract

Background The purpose of this study was to develop a swine model of surgically induced blood loss to evaluate the performances of a new autotransfusion system allowing red blood cells and platelets preservation while collecting, washing and concentrating hemorrhagic blood intraoperatively. Methods Two types of surgically induced blood loss were used in 12 minipigs to assess system performance and potential animal complications following autotransfusion: a cardiac model (cardiopulmonary bypass) and a visceral model (induced splenic bleeding). Animal clinical and hematological parameters were evaluated at different time-points from before bleeding to the end of a 72-hour post-transfusion period and followed by a post-mortem examination. System performances were evaluated by qualitative and quantitative parameters. Results All animals that received the autotransfusion survived. Minimal variations were seen on the red blood cell count, hemoglobin, hematocrit at the different sampling times. Coagulation tests failed to show any hypo or hypercoagulable state. Gross and histologic examination didn’t reveal any thrombotic lesions. Performance parameters exceeded set objectives in both models: heparin clearance (≥ 90%), final heparin concentration (≤ 0.5 IU/mL), free hemoglobin washout (≥ 90%) and hematocrit (between 45% and 65%). The device treatment rate of diluted blood was over 80 mL/min. Conclusions In the present study, both animal models succeeded in reproducing clinical conditions of perioperative cardiac and non-cardiac blood loss. Sufficient blood was collected to allow evaluation of autotransfusion effects on animals and to demonstrate the system performance by evaluating its capacity to collect, wash and concentrate red blood cells and platelets. Reinfusion of the treated blood, containing not only concentrated red blood cells but also platelets, did not lead to any postoperative adverse nor thrombogenic events. Clinical and comparative studies need to be conducted to confirm the clinical benefit of platelet reinfusion.

Combined Platelet and Red Blood Cell Recovery during On-pump Cardiac Surgery Using same™ by i-SEP Autotransfusion Device: A First-in-human Noncomparative Study (i-TRANSEP Study)

“…The blood processing by the device has been extensively described in published preclinical reports. 16,17 Briefly, shed blood is collected and heparinized through a dual-lumen suction line in a sterile blood collection reservoir (including a 40-μm filter) previously primed with 200 ml of the heparinized 0.9% NaCl solution (heparinized saline drip 25,000 U/l). The salvaged blood is then treated by the device with both filtration and washing with 0.9% NaCl solution.…”

“…Preclinical studies recently demonstrated a high performance in both red blood cell recovery and plasma proteins and heparin washing. 16,17 Further, the i-SEP device achieved a significant platelet recovery with minimal platelet activation while maintaining platelet ability to be activated in vitro. 16 Our objective was to evaluate in a first-in-human study the cell recovery performance and the biologic safety of the i-SEP device during on-pump cardiac surgery.…”