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Pathologic Blood Samples Tolerate Exposure to Vibration and High Turbulence in Simulated Drone Flights, but Plasma Samples Should be Centrifuged After Flight
Johannessen KA, Wear NKS, Toska K, Hansbo M, Berg JP, Fosse E
IEEE journal of translational engineering in health and medicine. 2021;9:4000110
Abstract
OBJECTIVE Most of the previous studies of drone transport of blood samples examined normal blood samples transported under tranquil air conditions. We studied the effects of 1- and 2-hour drone flights using random vibration and turbulence simulation (10-30 g-force) on blood samples from 16 healthy volunteers and 74 patients with varying diseased. METHODS Thirty-two of the most common analytes were tested. For biochemical analytes, we used plasma collected in lithium heparin tubes with and without separator gel. Gel samples were analyzed for the effect of separation by centrifugation before or after turbulence. Turbulence was simulated in an LDS V8900 high-force shaker using random vibration (range, 5-200 Hz), with samples randomly allocated to 1- or 2-hour flights with 25 or 50 episodes of turbulence from 10 to 30 G. RESULTS For all hematologic and most biochemical analytes, test results before and after turbulence exposure were similar (bias < 12%, intercepts < 10%). However, aspartate aminotransferase, folate, lactate dehydrogenase and lipid index increased significantly in samples separated by gel and centrifugation prior to vibration and turbulence test. These changes increased form 10 G to 30 G, but were not observed when the samples were separated after vibration and turbulence. CONCLUSIONS Whole blood showed little vulnerability to turbulence, whereas plasma samples separated from blood cells by gel may be significantly influenced by turbulence when separated by spinning before the exposure. Centrifugation of plasma samples collected in tubes with separator gel should be avoided before drone flights that could be subject to turbulence.
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Effect of parachute delivery on red blood cell (RBC) and plasma quality measures of blood for transfusion
Bates M, Watts S, Doughty H, Woolley T, Miles A, Barry L, Jenner D, Sedman A, Purcell R, Kirkman E
Transfusion. 2021;61 Suppl 1:S223-s233
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Editor's Choice
Abstract
BACKGROUND Parachute airdrop offers a rapid transfusion supply option for humanitarian aid and military support. However, its impact on longer-term RBC survival is undocumented. This study aimed to determine post-drop quality of RBCs in concentrates (RCC), and both RBCs and plasma in whole blood (WB) during subsequent storage. STUDY DESIGN AND METHODS Twenty-two units of leucodepleted RCC in saline, adenine, glucose, mannitol (SAGM) and 22 units of nonclinical issue WB were randomly allocated for air transportation, parachute drop, and subsequent storage (parachute), or simply storage under identical conventional conditions (4 ± 2°C) (control). All blood products were 6-8 days post-donation. Parachute units were packed into Credo Cubes, (Series 4, 16 L) inside a PeliCase (Peli 0350) and rigged as parachute delivery packs. Packs underwent a 4-h tactical flight (C130 aircraft), then parachuted from 250 to 400 ft before ground recovery. The units were sampled aseptically before and after airdrop at weekly intervals. A range of assays quantified the RBC storage lesion and coagulation parameters. RESULTS Blood units were maintained at 2-6°C and recovered intact after recorded ground impacts of 341-1038 m s(-2) . All units showed a classical RBC storage lesion and increased RBC microparticles during 42 days of storage. Fibrinogen and clotting factors decreased in WB during storage. Nevertheless, no significant difference was observed between Control and Parachute groups. Air transportation and parachute delivery onto land did not adversely affect, or shorten, the shelf life of fresh RBCs or WB. DISCUSSION Appropriately packaged aerial delivery by parachute can be successfully used for blood supply.
PICO Summary
Population
Units of red cells and whole blood (WB), (n= 44).
Intervention
Air transportation, parachute drop, and subsequent storage (Parachute, (n= 24).
Comparison
Storage under identical conventional conditions (Control, n= 20).
Outcome
Blood units were maintained at 2-6°C and recovered intact after recorded ground impacts of 341-1038 m s-2. All units showed a classical red blood cell (RBC) storage lesion and increased RBC micro particles during 42 days of storage. Fibrinogen and clotting factors decreased in whole blood during storage. Nevertheless, no significant difference was observed between Control and Parachute groups. Air transportation and parachute delivery onto land did not adversely affect, or shorten, the shelf life of fresh RBCs or WB.
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Personalized Collection of Plasma from Healthy Donors: A Randomized Controlled Trial of a Novel Technology-Enabled Nomogram
Hartmann J, Ragusa MJ, Burchardt ER, Manukyan Z, Popovsky MA, Leitman SF
Transfusion. 2021
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Abstract
BACKGROUND Source plasma is essential to support the growing demand for plasma-derived medicinal products. Supply is short, with donor availability further limited by the COVID-19 pandemic. This study examined whether a novel, personalized, technology-based nomogram was non-inferior with regard to significant hypotensive adverse events (AEs) in healthy donors. STUDY DESIGN AND METHODS IMPACT (IMproving PlasmA CollecTion) was a prospective, multi-center, double-blinded, randomized, controlled trial carried out between January 6 and March 26, 2020 in three U.S. plasma collection centers. Donors were randomized to the current simplified 1992 nomogram (control) or a novel Percent Plasma Nomogram (PPN) with personalized target volume calculation (experimental). Primary endpoint was the rate of significant hypotensive AEs. Non-inferiority (NI) was tested with a margin of 0.15%. Collected plasma volume was a secondary endpoint. RESULTS 3,443 donors (Mean [SD] BMI: 32 (7.74) kg/m(2) ; 65% male) underwent 23,137 donations (Median [range]: 6 [1-22] per subject). Ten significant hypotensive AEs were observed (6 control; 4 experimental), with model-based AE incidence rate estimates (95% CI) of 0.051% (0.020%, 0.114%) and 0.035% (0.010%, 0.094%), respectively (p=0.58). NI was met at an upper limit of 0.043% versus the predefined margin of 0.15%. There was no statistical difference between total AE (all AE types: p=0.32). Mean plasma volume collected was 777.8 mL (control) versus 841.7 mL (experimental); an increase of 63.9 mL per donation (8.2%; p<0.0001). CONCLUSION This trial showed that a novel personalized nomogram approach in healthy donors allowed approximately 8% more plasma per donation to be collected without impairing donor safety. This article is protected by copyright. All rights reserved.
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Randomized controlled trial of 7, 28, vs 42 day stored red blood cell transfusion on oxygen delivery (VO(2) max) and exercise duration
Bennett-Guerrero E, Rizwan S, Rozensky R, Romeiser JL, Brittelli J, Makaryus R, Lin J, Galanakis DK, Triulzi DJ, Moon RE
Transfusion. 2020
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Editor's Choice
Abstract
BACKGROUND Few studies have rigorously assessed the impact of red blood cell (RBC) transfusion on oxygen delivery. Several large trials demonstrated no clinical outcome differences between transfusion of shorter-storage vs prolonged-storage RBCs. These trials did not directly assess functional measures of oxygen delivery. Therefore, it is not clear if 42-day stored RBCs deliver oxygen as effectively as 7-day stored RBCs. STUDY DESIGN AND METHODS Leukocyte-reduced RBCs were collected by apheresis in AS-3. Thirty subjects were randomized (1:1:1) to receive 2 units of autologous RBCs at either 7, 28, or 42 days following donation. VO(2) max testing, using a standardized protocol to exhaustion, was performed 2 days before (Monday) and 2 days after (Friday) the transfusion visit (Wednesday). The primary endpoint was the percent increase in VO(2) max between Monday and Friday. The secondary endpoint was the percent change in duration of exercise for the same time points. RESULTS Hemoglobin levels decreased by 2.8 ± 1.4 g/dL after donation and increased by 2.1 ± 0.6 g/dL after transfusion. This change in hemoglobin was associated with expected decreases (then increases after transfusion) in VO(2) max and exercise duration. No differences were observed between 7-day and 42-day RBC transfusion for percent increase in median [IQR] VO(2) max (10.5 [0.2-17.3] vs 10.9 [5.7-16.8], P = .41) or for percent increase in exercise duration (5.4 [4.1-6.9] vs 4.9 [2.0-7.2], P = .91), respectively. Results were similar for 28-day RBCs and were consistent across the ITT and per-protocol analysis populations. CONCLUSION These data indicate that 42-day, 28-day, and 7-day RBCs have similar ability to deliver oxygen.
PICO Summary
Population
Blood donors (n= 30).
Intervention
2 units of autologous red blood cells (RBCs) at 7 days following donation (n= 10).
Comparison
2 units of autologous RBCs at either 28 days (n= 10), or 42 days following donation (n= 10).
Outcome
Haemoglobin levels decreased by 2.8 ± 1.4 g/dL after donation and increased by 2.1 ± 0.6 g/dL after transfusion. This change in haemoglobin was associated with expected decreases (then increases after transfusion) in VO(2) max and exercise duration. No differences were observed between 7-day and 42-day RBC transfusion for percent increase in median [IQR] VO(2) max (10.5 [0.2-17.3] vs 10.9 [5.7-16.8]) or for percent increase in exercise duration (5.4 [4.1-6.9] vs 4.9 [2.0-7.2]), respectively. Results were similar for 28-day RBCs and were consistent across the ITT and per-protocol analysis populations.
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A comparative study of five plateletpheresis machines in a tertiary care center of India: AmiCORE vs COM.TEC vs Haemonetics MCS+ vs Spectra Optia vs Trima Accel
Arcot PJ, Kumar K, Coshic P, Andriyas V, Mehta V
Journal of clinical apheresis. 2020
Abstract
BACKGROUND Single donor apheresis platelets are superior in quality, but their usage is limited in a developing country due to cost and time constraints. Hence the product obtained must exceed in terms of yield, donor safety and technical convenience. Previous literature available on cell separators is on older versions. AIMS Prospective comparison of 5 latest cell separators (AmiCORE, COM.TEC, Haemonetics MCS+, SpectraOptia and TrimaAccel) for product yield, performance variables and donor adverse effects. MATERIAL & METHODS From October 2019 - March 2020, 1108 donors were randomly allotted to a cell separator. Post-donation sample was taken from the donor 15-20 minutes after procedure completion. The platelet yield from the product collected was measured twice (day 0 and day 1). Donor demography, pre-and post-procedural donor peripheral blood values, performance and product variables were statistically analyzed. RESULTS AmiCORE had an optimal collection efficacy (44.6%) and collection rate (0.037 x 1011/minute). Haemonetics MCS+ had a better collection efficacy (48.4%) and rate (0.038 x 1011/minute). Spectra Optia achieved least procedural time (59.5 minutes), donor adverse effects (6.3%); highest collection efficacy (52.8%) and rate (0.056 x 1011/minute). Trima Accel achieved highest collection rate (0.056 x 1011/minute) and the least product volume (228 ml). CONCLUSION Highest collection efficacy was achieved by Trima Accel, highest collection rate by Trima Accel and Spectra Optia, lowest donor adverse effects by Spectra Optia and least number of procedural troubleshooting by COM.TEC. Apart from this, fiscal factors and service availability also need to be considered before choosing a cell separator.
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Quality assessment of red blood cell suspensions derived from pathogen-reduced whole blood
Kumukova I, Trakhtman P, Starostin N, Borsakova D, Ignatova A, Bayzyanova Y
Vox sanguinis. 2020
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Editor's Choice
Abstract
BACKGROUND We used laboratory indicators to evaluate the quality of pathogen-reduced red blood cell suspension (RBCS) compared with gamma-irradiated RBCS. MATERIALS AND METHODS To determine biochemical and metabolic parameters of RBCS, we obtained 50 whole blood units from healthy volunteers and randomized them into 2 groups: 25 were pathogen-reduced, and then, RBCS prepared from them. RBCS from the other 25 was gamma-irradiated. Sampling was carried out on day zero before and after treatment and at 7, 14, 21 and 28 days. To determine lymphocyte inactivation, we collected another 35 whole blood units. Each was sampled to form 3 study groups: untreated, gamma-irradiated and pathogen-reduced. Daily sampling was carried out during 3 days of storage. RESULTS The quality of RBCS from both groups was largely the same, except for haemolysis and red blood cell fragility, which were more pronounced in the pathogen-reduced group. This finding limited the shelf life of pathogen-reduced RBCS to 14 days. Lymphocyte viability was significantly reduced after both treatments. Proliferation of lymphocytes after pathogen reduction was reduced to the detection limit, while low-level proliferation was observed in gamma-irradiated samples. CONCLUSION Pathogen-reduced red blood cells have acceptable quality and can be used for transfusion within 14 days. Results of inactivation of lymphocytes demonstrate that pathogen reduction technology, applied on WB, can serve as an alternative to irradiation.
PICO Summary
Population
Whole blood units from healthy donors (n= 50).
Intervention
Pathogen-reduction with riboflavin and ultraviolet light (n= 25).
Comparison
Gamma‐irradiation (n= 25).
Outcome
The quality of RBCS from both groups was largely the same, except for haemolysis and red blood cell fragility, which were more pronounced in the pathogen-reduced group. This finding limited the shelf life of pathogen-reduced RBCS to 14 days.
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Metabolomics study of platelet concentrates photochemically treated with amotosalen and UVA light for pathogen inactivation
Johannsson F, Arnason NA, Landro R, Guethmundsson S, Sigurjonsson OE, Rolfsson O
Transfusion. 2019
Abstract
BACKGROUND The risk of bacterial contamination and the deterioration of platelet (PLT) quality limit the shelf-life of platelet concentrates (PCs). The INTERCEPT pathogen inactivation system reduces the risk of pathogen transmission by inhibiting nucleic acid replication using a combination of a photo-reactive compound and UVA illumination. The goal of this study was to investigate the effects the INTERCEPT system has on the PLT metabolome and metabolic activity. STUDY DESIGN AND METHODS Paired units of buffy coat-derived PCs were generated using a pool and split strategy (n = 8). The paired PCs were either treated with the INTERCEPT system or left untreated. Samples were collected on Days 1, 2, 4, and 7 of storage. Ultra-performance chromatography coupled with time-of-flight mass spectrometry was used to analyze the extra- and intracellular metabolomes. Constraint-based metabolic modeling was then used to predict the metabolic activity of the stored PLTs. RESULTS A relatively large number of metabolites in the extracellular environment were depleted during the processing steps of the INTERCEPT system, in particular, metabolites with hydrophobic functional groups, including acylcarnitines and lysophosphatidylcholines. In the intracellular environment, alterations in glucose and glycerophospholipid metabolism and decreased levels of 2-hydroxyglutarate were observed following the INTERCEPT treatment. Untargeted metabolomics analysis revealed residual amotosalen dimers present in the treated PCs. Systems-level analysis of PLT metabolism indicated that the INTERCEPT system does not have a significant impact on the PLT energy metabolism and nutrient utilization. CONCLUSIONS The INTERCEPT system significantly alters the metabolome of the stored PCs without significantly influencing PLT energy metabolism.
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Coagulation Factor Activities Changes Over 5 Days in Thawed Fresh Frozen Plasma Stored at Different Initial Storage Temperatures
Noordin SS, Karim FA, Mohammad WMZBW, Hussein AR
Indian Journal of Hematology & Blood Transfusion : an Official Journal of Indian Society of Hematology and Blood Transfusion. 2018;34((3)):510-516.
Abstract
Thawed plasma is fresh frozen plasma (FFP) that has been stored for 5 days at 1-6 degrees C. Duration of storage and different storage temperatures might affect the coagulation factor activity in thawed FFP. This study measured the changes of coagulation factor activities over 5 days in thawed FFP and stored at two different initial storage temperatures. Thirty-six units of FFP, which consisted of nine units each from blood groups A, B, AB, and O, were thawed at 37 degrees C. Each unit was divided into two separate groups (Group A and Group B) based on initial storage temperature. The first group was stored at 2-6 degrees C for 5 days (Group A). The second group was stored at 20-24 degrees C for initial 6 h followed by 2-6 degrees C for 5 days (Group B). Prothrombin time (PT), activated partial thromboplastin time (APTT), coagulation factor activities of fibrinogen, factor (F) II, FV, FVII, FVIII, FIX, FX, and von Willebrand factor antigen (vWF Ag) were assessed at baseline after thawing, at 6 h, and on days 1, 3, and 5 of storage for both groups. All coagulation factors mean activities in both storage groups decreased significantly over 5 days of storage. The mean FVIII activity at day 5 of storage was 36.9% in Group A and 39.8% in Group B. The other coagulation factors mean activities were > 50% on day 5 of storage in both groups. The coagulation factor activities of thawed FFP stored for 5 consecutive days were reduced in the two storage groups but most of the activities were still above 30%. This study suggests that thawed FFP stored for 5 days has the potential to ameliorate coagulation factor deficiencies in affected patients.
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Impact of the platelet washing process on in vitro platelet properties, and the levels of soluble CD40 ligand and platelet-derived microparticles in the storage media
Oikawa S, Minegishi M, Endo K, Kawashima W, Kosunago S, Oyama M, Suzuki K, Shimizu H
Transfusion. 2018
Abstract
BACKGROUND A new platelet (PLT) additive solution, bicarbonated Ringer's solution supplemented with acid-citrate-dextrose Formula A, termed BRS-A, as well as a new automated closed system cell processor for washing PLTs have recently been developed. This study evaluated the in vitro properties of PLTs with the automated system versus the manual method, using the BRS-A additive solution for washing and storage. METHODS ABO-identical apheresis PLTs in 100% plasma were pooled and split equally for control (in 100% plasma or a manual method) and test (ACP215 automated system) units. In vitro characteristics of PLTs washed with the automated system were compared to those of PLTs in 100% plasma (Study 1) or washed with a manual method (Study 2) during the 7-day storage. RESULTS In Study 1, hypotonic shock response, aggregation response, mitochondrial membrane potential, adenosine triphosphate, and CD42b mean fluorescence intensity were comparable in the control and test groups during the 7-day storage. CD62P expression was lower in the test group than controls on Days 3 and 7. The level of platelet-derived microparticles (PDMPs) in the test group on Days 1 and 2 were higher than those in controls. In contrast, the levels of soluble CD40 ligand (sCD40L) and regulated upon activation of normal T-cell expressed and secreted (RANTES) in the test units were lower than controls. In Study 2, no significant differences were found in all in vitro properties except for PLT count and the levels of PDMPs in the test units were higher than controls during storage. CONCLUSION Apheresis PLTs washed with the automated system using BRS-A additive solution maintained in vitro properties during storage. Washing methods influenced PDMP levels but not sCD40L and RANTES.
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Hemostatic efficacy of pathogen-inactivated- versus untreated- platelets: a randomized controlled trial
van der Meer P F, Ypma P F, van Geloven N, van Hilten J A, van Wordragen-Vlaswinkel R J, Eissen O, Zwaginga J J, Trus M, Beckers E A M, Te Boekhorst P, et al
Blood. 2018;132((2):):223-231
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Abstract
Pathogen inactivation of platelet concentrates reduces the risk of blood-borne infections. However, its effect on platelet function and hemostatic efficacy of transfusion is unclear. We conducted a randomized noninferiority trial comparing the efficacy of pathogen inactivated platelets using riboflavin and ultraviolet B illumination technology (intervention) compared to standard plasma-stored platelets (control) for the prevention of bleeding in patients with hematologic malignancies and thrombocytopenia. The primary outcome parameter was the proportion of transfusion treatment periods in which the patient had grade 2 or higher bleeding as defined by World Health Organization (WHO) criteria. Between November 2010 and April 2016, 469 unique patients were randomized to 567 transfusion treatment periods (283 in the control arm, 284 in the intervention arm). There was a 3% absolute difference in grade ≥ 2 bleeding in the intention-to-treat analysis: 51% of the transfusion treatment periods in the control arm and 54% in the intervention arm (95% CI -6 to 11, p-value for noninferiority 0.012). In the per-protocol analysis, however, difference in grade ≥ 2 bleeding was 8%: 44% in the control arm and 52% in the intervention arm (95% CI -2 to 18, p-value for noninferiority 0.19). Transfusion increment parameters were about 50% lower in the intervention arm. There was no difference in the proportion of patients developing HLA class I alloantibodies. In conclusion, the noninferiority criterion for pathogen inactivated platelets was met in the intention-to-treat analysis. This finding was not demonstrated in the per protocol analysis. (The Netherlands National Trial Registry number: NTR2106).
