engleski

New platelet apheresis device: AmiCORE software 2.1 first experience report

Background: University Hospital Osijek, an educational and scientific facility of the Faculty of Medicine, Josip Juraj Strossmayer University Osijek, is the second largest blood collection establishment in Croatia, performing more than 1.500 platelet apheresis procedures per year. We evaluated the AmiCORE® Apheresis System (Fresenius Kabi, Germany) with software version 2.1, which adds the capability to collect platelets in additive solution (PAS), and to collect concurrent plasma (cPlasma). This new device is based on the Amicus® separation technology currently used in our center, and also includes process leukoreduction and saline infusion for donor comfort. The AmiCORE offers a reduced size and simplified handling for operators. AmiCORE is CE marked and is now used in many centers in Europe and Asia. Aims: The evaluation intended to demonstrate AmiCORE’s performance under routine conditions to collect single donor platelets in PAS and cPlasma, 5-day storage characteristics of the platelets, and plasma product quality. Methods: All donor room staff (2) involved in the evaluation were trained on the AmiCORE technology by Fresenius Kabi instructors prior to operating the device. Regular donors fulfilling the general requirements of donor eligibility on the day of donation and a minimum platelet precount of 250 × 109 /L were selected to donate double dose platelets (6.0 × 1011) and 200 ml cPlasma. All procedures were done at a citrate infusion rate setting of 1, 4 mg/kg/min and a fixed AC ratio of 9:1. Standard settings for inlet and return flow rates were applied to start at 110 ml/min and 150 ml/min, respectively. Flow rates were adjusted only if demanded by donor’s vein condition. AmiCORE’s automated PAS addition feature was used to store platelets in 65% InterSol and 35% plasma. Ten pre-trial donations were performed to adjust AmiCORE for optimum performance, followed by 24 consecutive procedures for the evaluation. Half of the collections were transfused and 12 were used for evaluation of in vitro platelet quality parameters at Days 0, 1, 4 and 5. Total protein, volume and residual RBCs and WBCs were measured for all 24 cPlasma products. Data are given as mean values with min/max ranges of results measured or recorded. Results: No adverse events were reported, even not citrate triggered symptoms. AmiCORE’s automatic adjustment of flow rates avoided flow alarms and no intervention of operators was necessary. No other alarms or failures occurred during the evaluation. Mean platelet yield was 6.56 × 1011 vs. 6.0 × 1011 programmed target yield, and average procedure time was 70 minutes. All platelet units met the EU standard of < 1.0 × 106 leukocytes. Glucose, lactate, pH, HCO3, LDH, pCO2 and pO2 were measures at expected levels at Days 0, 1, 4 and 5. Swirling was observed in all platelet products throughout the storage period. Microbiological testing at the end of storage confirmed sterility of the platelet products. Total protein was > 50 g/ L in all cPlasma products, and mean volume was 201.6 ml. Residual RBCs and WBCs were at acceptable levels for therapeutic plasma products. Conclusions: AmiCORE met all criteria for platelet and cPlasma products as per regulatory requirements and institute’s internal standard. It is an easy to use, stable apheresis platform to collect platelets in additive solution and concurrent plasma with minimal variation from predefined targets of product quality after operator training and fine tuning of device setup.

platelet, blood donation, collection, apheresis

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