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28 protocols using trima accel

1

Platelet Production Protocols across Multiple Regions

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Components from NHSBT were manufactured according to UK guidelines.3 Both plasma and pooled buffy coat (BC)‐derived platelets suspended in platelet additive solution (PAS) were obtained from manual processing of whole blood (WB). Apheresis machines (Trima Accel, Terumo BCT, Surrey, UK) were used to generate both leukoreduced PCs suspended in plasma and plasma alone.
Components from SBB were manufactured according to Council of Europe guidelines.4 Apheresis machines (Trima Accel, Terumo BCT; and MCS+, Haemonetics Corp., Braintree, Massachusetts), were used to manufacture leukoreduced PCs suspended in PAS and plasma alone.
The Irish Blood Transfusion Service (IBTS) produced pooled BC‐derived PCs in PAS, according to Council of Europe guidelines,4 with use of the Terumo Automated Centrifuge and Separator Integration (TACSI) system, as previously described.18
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2

Platelet Apheresis and Storage Characteristics

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Platelets were collected by standard apheresis procedures from 6 healthy donors (COBE Spectra®, n=4 and Trima Accel®, n=2, Terumo BCT, Lakewood, CO, USA). Acid citrate dextrose was used as anticoagulant [15] . The PC units contained 28828 x10 9 platelets on the day of donation (day 0). All PCs were irradiated with 25Gy on day 0 (Gammacell 3000 Elan, MDS Nordion, Ottawa, Canada). The PCs were stored in bags integrated to each collection kit on an agitator (Model LPR-3, Melco Engineering, Glendale, CA, USA) in an incubator (Helmer PC2200, Helmer, Noblesville, IN, USA) with a stable temperature of 22±2°C.
Samples were taken aseptically with a sampling bag (MacoPharma, Tourcoing, France) from each PC on days 1, 5, 7 and 12 (one PC on day 13 for flow cytometry measurements). One PC (prepared by COBE Spectra) had reduced swirling on day 12, thus as a comparison we performed flow cytometry measurements on samples from 5 additional PCs with decreased swirling (on day 15-22, collected by apheresis Trima Accel®, n=3 and Spectra Optia®, n=2, Terumo BCT). The eBDS system was used to check for bacterial growth (Haemonetics Corporation, Braintree, MA, USA).
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3

Convalescent Plasma Collection Protocol

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Convalescent plasma was obtained by apheresis using the Trima Accel automated blood collection system (Terumo BCT, Lakewood, CO). Plasma (600 mL) was collected from each donor and divided into two 300-mL units. Each donor had a documented history of laboratory-confirmed SARS-CoV-2 infection on the basis of a positive RT-PCR test result. All plasma was donated by recovered and healthy COVID-19 patients who had been asymptomatic for ≥14 days. Donors were between 23 and 67 years old. All donors provided written informed consent and tested negative for SARS-CoV-2 by RT-PCR. If eligible according to standard blood donor criteria, donors were enrolled in a frequent plasmapheresis program. Donors were negative for anti–human leukocyte antigen antibodies, hepatitis B virus, hepatitis C virus, HIV, human T-lymphotropic virus I/II, Chagas disease, West Nile virus, Zika virus, and syphilis, per standard blood banking practices.
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4

Isolation of Switched Memory B Cells

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This study has been approved by Héma-Québec's Research Ethics Committee. Regular platelet donors who agreed to participate in this study have all signed an informed consent. Peripheral blood mononuclear cells (PBMC) from healthy donors were recovered from leukoreduction chambers of plateletpheresis apparatus (Trima Accel, Terumo BCT, Lakewood, CO) and stored frozen as previously described [54 (link)]. Switched memory CD19+ B lymphocytes were isolated from PBMC by a two-step negative selection using the EasySep™ B-cell Enrichment Kit and EasySep™ custom cocktail removing all IgD- and IgM-positive cells (STEMCELL Technologies, Vancouver, Canada), as previously described [51 (link)]. The purity of CD19+IgDIgM intact switched memory B lymphocytes was higher than 95%, as determined by flow cytometry.
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5

Plateletpheresis Procedure Evaluation

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All plateletphereses were performed between 7:00 and 11:00 AM using the Amicus separator (Fenwal, Deerfield, IL, USA) and the Trima Accel (Terumo BCT, Denver, CO, USA). ACD-A anticoagulant was dripping during the whole apheresis procedure (which lasted 70 min on average) at a whole blood to anticoagulant ratio of 10:1 and a mean flow rate of 60 mL/min, according to our standard operating procedure manual. Blood samples were drawn from the system’s piggy bag both at the beginning (time-1) of the procedure and 10’ after finishing plateletpheresis (time-2). In addition, a third sample was drawn 15 days later from the participating donors (time-3). We used the trace-free Vacutainer tubes (Becton-Dickinson, Franklin Lakes, NJ) for this performance. All sera samples were frozen at −70 °C until analytic tests were performed.
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6

Platelet Donation and Serum TPO Levels

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Plateletpheresis procedures were performed on two types of cell separators (TRIMA ACCEL®, Terumo BCT Lakewood, Colorado and AMICUS®, Fresenius Kabi, Germany). The mean platelet yield of collected platelet product was ≥3 × 1011 platelets, fulfilling the requisite quality control criteria.[2 ]
Before the procedure, the donor was briefed about the procedure and a written informed consent was obtained. Antecubital veins on both sides were assessed for their suitability for phlebotomy. Sampling was done from the dorsum of the hand for blood grouping and transfusion transmissible infections screening of the donor. For the evaluation of serum TPO levels and platelet counts, 10-ml blood was drawn (2 ml in EDTA vacutainer and an 8 ml of blood in plain vacutainer) before platelet donation, at the end of the donation (apheresis), and at the 3rd- and 5th- postdonation day. At each time point, platelet parameters, including platelet count, mean platelet volume (MPV), and platelet distribution width (PDW), were estimated using ORION 60™ hematology analyzer.
Serum TPO levels were determined using quantitative sandwich enzyme-linked immunosorbent assay technique (Raybiotech, USA) on stored serum samples, as per the protocol of the manufacturer.
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7

Apheresis Platelet Concentrate Transfusion

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Apheresis platelet concentrates of blood group O stored for a median of 1 day (range: 1‐3) were used. The platelet concentrates were produced by the blood bank at Sahlgrenska University Hospital using an apheresis device (Trima Accel; Terumo BCT Europe, Zaventem, Belgium) in accordance with European guidelines.17 Autologous plasma was used as storage medium. The mean platelet count in the platelet concentrates was 1747 ± 41 × 109 L−1. In vitro addition of 120 × 106 platelets to a 1‐mL blood sample was tested. This corresponds to an increase in platelet count achieved by transfusion of approximately three apheresis units to a 70‐kg patient. By using the platelet concentration in the individual concentrate, the specific volume to add from the concentrate was calculated. The mean volume of platelet concentrate added was 69 ± 1.6 μL.
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8

Platelet Apheresis Protocols Comparison

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The blood center had the MCS+ (software version 2-UPP-A.2-IE, Haemonetics, Braintree MA, USA), Trima Accel, (software version 6.0, Terumo BCT, Lakewood, CO, USA) and Spectra Optia (Terumo BCT, Lakewood, CO, USA) equipment for platelet apheresis. The universal platelet protocol in the MCS+ equipment uses intermittent flow centrifugation in which the whole blood is pumped into the spinning bowl and platelet components are pushed upward and inward to the appropriate bag during each cycle. The system then concentrates the platelet product and suspends it in the platelet additive solution. The Trima Accel and Spectra Optia equipment works on continuous flow centrifugation and the leukoreduction system (LRS) chamber separates platelets from white blood cells using the elutriation principle. Donors underwent collection in one of these apheresis equipment. The donation endpoint, i.e., target yield, was set based on the estimated procedural time, donor comfort during the procedure, donor complications and estimated post-donation platelet count. The maximum procedure duration was set below 130 minutes for all the procedures. The blood center preferred donors with higher platelet counts for the MCS+ equipment due to the longer procedure duration.
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9

Plasma Donation from Recovered COVID-19 Patients

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Recovered COVID-19 patient who had received a COVID-19 diagnosis by the Québec Provincial Health Authority and met the donor selection criteria for plasma donation in use at Héma-Québec were recruited. The participant was allowed to donate plasma at least 14 days after complete resolution of COVID-19 symptoms. A volume of 500 mL–750 mL of plasma was collected by plasmapheresis (TRIMA Accel, Terumo BCT). Disease severity (date of symptoms onset, end of symptoms, type, and intensity of symptoms, need for hospitalization/ICU) was documented using a questionnaire administered at the time of recruitment. For additional details of CCP-5 (sex, age, blood group of the convalescent donor and day of collection post infection, please refer to key resources table.
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10

COVID-19 Convalescent Plasma Collection

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Using the Trima Accel cell separator (Terumo BCT, Lakewood, CO, USA), a maximum volume of 650 mL of COVID-19 CP was collected in the course of a donation event. Plasma pathogen reduction was performed applying the INTERCEPT blood system (Cerus Corporation Europe BV, Amersfoort, The Netherlands) according to manufacturer’s instructions. The collected CP was stored at ≤−25 °C until further usage.
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