Senior Medical Manager Macopharma Atlanta, Georgia, United States
Background/Case Studies: Platelet pooling from buffy coats is widely adopted in Europe and Asia, but remains underutilized in Latin America, often due to misconceptions about efficacy and safety. The Blood Bank of the National Medical Center "Siglo XXI" (IMSS), a major referral center in Mexico, initiated a study to assess the quality and functionality of leukoreduced platelet concentrates (LPC) derived from buffy coat pooling and suspended in platelet additive solution (PAS). The primary goal was to determine compliance with national and European standards and evaluate clotting functionality through thromboelastography (TEG), thus promoting evidence-based transfusion practices in Latin America.
Study
Design/Methods: A total of 600 whole blood units (WB) were processed using standardized protocols. Red blood cells (RBC), plasma, and buffy coats (BC) were separated with Macopharma equipment. RBCs underwent in-line pre-storage leukoreduction. Four ABO-compatible BCs were pooled with PAS and processed to obtain LPCs. Quality control tests were performed on RBCs (volume, hemoglobin, hematocrit, residual leukocytes, sterility), plasma (proteins, factor VIIIc, residual cells), and LPCs (volume, platelet count, pH, leukocyte content, sterility). LPC functionality was assessed using TEG to measure maximum amplitude (MA), reflecting clot strength.
Results/Findings: RBCs achieved a mean volume of 253 ± 17.8 mL, hematocrit of 54.8 ± 2.84%, hemoglobin 44.5 ± 5.69 g/unit, and 99.3% compliance. Plasma showed total protein levels of 70.27 ± 6.95 g/L and factor VIIIc activity of 145.30 ± 79.25%, confirming quality. LPCs met and exceeded standards with a mean platelet content of 2.72 ± 0.41×10¹¹ per unit, residual leukocytes of 0.23 ± 0.26 × 10⁶, pH of 7 ± 0.08, and zero bacterial contamination in 84 samples. TEG results showed MA values consistently between 75–80 mm, indicating robust clot formation and superior platelet functionality. The use of PAS reduced plasma exposure by 60%, contributing to patient safety by minimizing transfusion-related reactions. Conclusions: This study validates the production of high-quality LPCs from buffy coat pooling with consistent compliance to EDQM and Mexican standards. Thromboelastography confirms excellent functional performance, dispelling myths about the inferiority of pooled platelets. These findings represent a significant advancement for transfusion medicine in Latin America, promoting a cost-effective, scalable, and evidence-based approach to platelet supply. The methodology supports improved patient outcomes, enhanced resource efficiency, and potential regional harmonization with international transfusion practices.
