Impact of the preparation method of red cell concentrates on transfusion indices in thalassemia patients: A randomized crossover clinical trial

Gamberini, Maria Rita; Fortini, Monica; Stievano, Alice; Calori, E; Riontino, Maria Vittoria; Ceccherelli, Giovanni; Venturelli, Donatella; Chicchi, Roberta; Biguzzi, Rino; Fagnoni, Francesco; Portararo, Giuseppina Angela; Lasagni, Donatella; Borotti, Elena; Buonocore, Ruggero; Govoni, Maurizio; Reverberi, Roberto

doi:10.1111/trf.16432

Cited by 3 publications

(11 citation statements)

References 17 publications

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“…In accordance with previously reported results [16], we measured a higher Hb content for P-RBCs prepared with method 1 (18-20% more than method 2). The RBCs count (18-23% more than method 2) and HCT levels increased accordingly.…”

Section: Discussionsupporting

confidence: 93%

“…In a recent one-year crossover clinical trial [ 16 ], the procedure suggested by the Thalassemia International Federation (here method 1) was compared with another method routinely used to prepare P-RBCs for βTM patients [ 9 ], where whole blood is first separated to obtain packed erythrocytes, which are subsequently filtered (here method 2). Method 1 was proved to produce P-RBCs with a higher content of Hb, which in turn resulted in a longer transfusion interval (14.8 vs. 14.2 mean days between two consecutive transfusion episodes).…”

Section: Discussionmentioning

confidence: 99%

“…Method 1 was proved to produce P-RBCs with a higher content of Hb, which in turn resulted in a longer transfusion interval (14.8 vs. 14.2 mean days between two consecutive transfusion episodes). Despite the trial by Gamberini and colleagues [ 16 ] has the merit to be the first attempt to find the most suitable product for βTM patients transfusion, several important aspects remain to be elucidated to identify the most effective and safest P-RBCs product.…”

Section: Discussionmentioning

confidence: 99%

“…Identifying the most efficient method to obtain P-RBCs with the highest content of Hb and the best safety features (minimum amount of haemolysis, storage lesions [ 10 , 11 , 12 , 13 ] and pro-inflammatory factors [ 14 , 15 ]) would significantly improve βTM patients’ QoL, reducing both the transfusion frequency and the risk of adverse effects. Clinical trials on βTM patients mostly focus on the efficacy of iron chelating agents, while almost no attention is dedicated to the transfusion therapy itself: to our knowledge, only a recent randomized crossover clinical trial tried to compare βTM patients treated with P-RBCs obtained with two alternative methods routinely used in the clinical practice to prepare leucodepleted RBCs [ 16 ]. In this study, the transfusion interval was improved after treating with P-RBCs with the highest Hb content.…”

Section: Introductionmentioning

confidence: 99%

“…Here we focused on the overall quality and characteristics of two routinely used P-RBCs, in order to identify differences in the alternative products that may have some long-term detrimental effects on patients. In the first method, which was proved to increase the transfusion interval [ 16 ], whole blood is leucodepleted and separated afterwards to remove plasma. In the second method, plasma and buffy coat are first removed and the remaining RBCs are then leucodepleted [ 8 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

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Comparison of Two Alternative Procedures to Obtain Packed Red Blood Cells for β-Thalassemia Major Transfusion Therapy

et al. 2021

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β-thalassemia major (βTM) patients require frequent blood transfusions, with consequences that span from allogenic reactions to iron overload. To minimize these effects, βTM patients periodically receive leucodepleted packed red blood cells (P-RBCs) stored for maximum 14 days. The aim of this study was to compare two alternative routine procedures to prepare the optimal P-RBCs product, in order to identify differences in their content that may somehow affect patients’ health and quality of life (QoL). In method 1, blood was leucodepleted and then separated to obtain P-RBCs, while in method 2 blood was separated and leucodepleted after removal of plasma and buffycoat. Forty blood donors were enrolled in two independent centers; couples of phenotypically matched whole blood units were pooled, divided in two identical bags and processed in parallel following the two methods. Biochemical properties, electrolytes and metabolic composition were tested after 2, 7 and 14 days of storage. Units prepared with both methods were confirmed to have all the requirements necessary for βTM transfusion therapy. Nevertheless, RBCs count and Hb content were found to be higher in method-1, while P-RBCs obtained with method 2 contained less K+, iron and storage lesions markers. Based on these results, both methods should be tested in a clinical perspective study to determine a possible reduction of transfusion-related complications, improving the QoL of βTM patients, which often need transfusions for the entire lifespan.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Comparison of Two Alternative Procedures to Obtain Packed Red Blood Cells for β-Thalassemia Major Transfusion Therapy

et al. 2021

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Modeling hemoglobin levels of patients chronically transfused with red blood cells

Carter

Dunham

2023

Transfusion

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Background Good models of chronic red blood cell (RBC) transfusion can improve care by accurately estimating time‐dependent hemoglobin (Hb) levels and clinically relevant transfusion parameters. Study Design and Methods A previously derived mathematical model based on overall Hb mass balance (HMB model) with input parameters of transfused units, transfusion efficiency, RBC lifespan, endogenous Hb, and transfusion interval was applied to three separate clinical studies spanning six transfusion conditions across patient populations with myelodysplastic syndrome (MDS) or thalassemia. Results The HMB model accurately predicted mean pretransfusion Hb levels for each ensemble cohort of patients with thalassemia or MDS. Dynamic changes in Hb levels were modeled as a function of changes in key input parameters. Improving the 24‐h post‐transfusion RBC survival from 72% to 86% can be used to either (1) reduce RBC usage by 15%–20% through longer transfusion intervals or (2) increase pretransfusion [Hb] by 8%–11% while maintaining a constant transfusion interval. Discussion The endogenous Hb level is introduced in the HMB model which represents the patient's self‐contribution to overall Hb levels via the autologous RBC lifecycle and was estimated to be 5.0 g/dL for patients with MDS or thalassemia. Transfusion therapy approaches and complementary therapeutics can target multiple, unique model inputs while monitoring net, overall impact on transfusion efficacy. Applying the HMB model to fit individual patient Hb fluctuations will be explored in the future.

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Modelling haemoglobin incremental loss on chronic red blood cell transfusions

Carter

Dunham

2022

Vox Sanguinis

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Background and Objectives: Understanding the impact of red blood cell (RBC) lifespan, initial RBC removal, and transfusion intervals on patient haemoglobin (Hb) levels and total iron exposure is not accessible for chronic transfusion scenarios. This article introduces the first model to help clinicians optimize chronic transfusion intervals to minimize transfusion frequency.Materials and Methods: Hb levels and iron exposure from multiple transfusions were calculated from Weibull residual lifespan distributions, the fraction effete RBC removed within 24-h (X e ) and the nominal Hb increment. Two-unit transfusions of RBCs initiated at patient [Hb] = 7 g/dl were modelled for different RBC lifespans and transfusion intervals from 18 to 90 days, and X e from 0.1 to 0.5. Results:Increased X e requires shorter transfusion intervals to achieve steady-state[Hb] of 9 g/dl as follows: 30 days between transfusions at X e = 0.5, 36 days at X e = 0.4, 42 days at X e = 0.3, 48 days at X e = 0.2 and 54 days at X e = 0.1. The same transfusion interval/X e pairs result in a steady-state [Hb] = 8 g/dl when the RBC lifespan was halved. By reducing transfused RBC increment loss from 30% to 10%, annual transfusions were decreased by 22% with iron addition decreased by 24%.Acute dosing of iron occurs at the higher values of X e on the day after a transfusion event.Conclusion: Systematic trends in fractional Hb incremental loss X e have been modelled and have a significant and calculatable impact on transfusion intervals and associated introduction of iron.

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Impact of the preparation method of red cell concentrates on transfusion indices in thalassemia patients: A randomized crossover clinical trial

Cited by 3 publications

References 17 publications

Comparison of Two Alternative Procedures to Obtain Packed Red Blood Cells for β-Thalassemia Major Transfusion Therapy

Comparison of Two Alternative Procedures to Obtain Packed Red Blood Cells for β-Thalassemia Major Transfusion Therapy

Modeling hemoglobin levels of patients chronically transfused with red blood cells

Modelling haemoglobin incremental loss on chronic red blood cell transfusions

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