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

Abstract

Background The average hemoglobin content of red cell concentrates (RCC) varies depending on the method of preparation. Surprisingly less data are available concerning the clinical impact of those differences. Study Design and Methods The effects of two types of RCC (RCC‐A, RCC‐B) on transfusion regime were compared in a non‐blinded, prospective, randomized, two‐period, and crossover clinical trial. RCC‐A was obtained by whole blood leukoreduction and subsequent plasma removal, RCC‐B removing plasma and buffy coat first, followed by leukoreduction. Eligible patients were adult, with transfusion‐dependent thalassemia (TDT). Results RCC‐A contained 63.9 (60.3–67.8) grams of hemoglobin per unit (median with 1st and 3rd quartile), RCC‐B 54.5 (51.0–58.2) g/unit. Fifty‐one patients completed the study. With RCC‐B, the average pre‐transfusion hemoglobin concentration was 9.3 ± 0.5 g/dl (mean ± SD), the average transfusion interval 14.2 (13.7–16.3) days, the number of RCC units transfused per year 39.3 (35.4–47.3), and the transfusion power index (a composite index) 258 ± 49. With RCC‐A, the average pre‐transfusion hemoglobin concentration was 9.6 ± 0.5 g/dl (+2.7%, effect size 0.792), the average transfusion interval 14.8 (14.0–18.5) days (+4.1%, effect size 0.800), the number of RCC units transfused per year 34.8 (32.1–42.5) (−11.4%, effect size −1.609), and the transfusion power index 272 ± 61 (+14.1%, effect size 0.997). All differences were statistically highly significant (p < .00001). The frequency of transfusion reactions was 0.59% with RCC‐A and 0.56% with RCC‐B (p = 1.000). Conclusion To reduce the number of RCC units consumed per year and the number of transfusion episodes, TDT patients should receive RCC with the highest average hemoglobin content.

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

“…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.…”

“…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).…”

“…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.…”

“…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.…”

“…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 ].…”