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Cold-stored leukoreduced CPDA-1 whole blood: in vitro quality and hemostatic properties
Joar Sivertsen1, Hanne Braathen1, Turid Helen Felli Lunde1
1Department of Immunology and Transfusion Medicine, Haukeland University Hospital, Bergen, Norway.
Insights
Leukoreducing citrate-phosphate-dextrose-adenine (CPDA-1) whole blood with a platelet-saving filter maintains hemostatic properties and extends shelf life to 35 days. This innovation supports simplified blood resupply and reduces wastage in critical settings.
Area of Science:
- Blood banking and transfusion medicine
- Hematology
- Biotechnology
Background:
- Leukoreduction of cellular blood components is mandated in some regions.
- Current platelet-saving filters for whole blood use citrate-phosphate-dextrose (CPD) storage.
- Utilizing citrate-phosphate-dextrose-adenine (CPDA-1) can extend whole blood shelf life from 21 to 35 days, improving logistics and reducing waste.
Purpose of the Study:
- To evaluate the in vitro quality and hemostatic properties of leukoreduced CPDA-1 whole blood.
- To assess the efficacy of a platelet-saving filter in conjunction with CPDA-1 storage.
Main Methods:
- CPDA-1 whole blood was leukoreduced using a platelet-saving filter and stored for 35 days.
- Evaluated parameters included European Directorate for the Quality of Medicines & HealthCare (EDQM) requirements, hematology, metabolic markers, thromboelastography, light transmission aggregometry, fibrinogen, factor VIII, and interleukin-6.
- Comparisons were made against non-leukoreduced blood at multiple time points.
Main Results:
- Leukoreduction achieved <1×10⁶ white blood cells and 87% platelet recovery on Day 1.
- No significant hemolysis (>0.8%) was observed.
- While thromboelastography parameters showed some reduction, platelet aggregometry and fibrinogen levels remained adequate; factor VIII levels were higher in the leukoreduced group by Day 35.
Conclusions:
- Leukoreduction of CPDA-1 whole blood using a platelet-saving filter preserves essential hemostatic functions.
- The findings support the development of integrated CPDA-1 whole blood collection systems with in-line platelet-saving filters.
- This approach offers potential benefits for blood supply chain management and patient care.
Background:
Some jurisdictions require leukoreduction of cellular blood components. The only whole blood collection set with a platelet-saving filter uses citrate-phosphate-dextrose (CPD) as storage solution. Substituting CPD with citrate-phosphate-dextrose-adenine (CPDA-1) increases shelf life from 21 to 35 days. This would simplify prehospital and rural resupply and reduce wastage. We investigated in vitro quality and hemostatic properties of CPDA-1 whole blood leukoreduced with a platelet-saving filter.
Study Design And Methods:
CPDA-1 whole blood was leukoreduced using a platelet-saving filter and stored 35 days. EDQM requirements, hematology, metabolic parameters, thromboelastography, light transmission aggregometry, fibrinogen, factor VIII, and interleukin-6 were measured on Days 0, 1, 14, 21, and 35 and compared to non-leukoreduced blood.
Results:
All units met EDQM requirements. Leukoreduction yielded residual white blood cell count <1 × 106 and 87% platelet recovery on Day 1. It caused reduction in thromboelastography parameters, but not aggregometry response. No hemolysis >0.8% was observed. Factor VIII was higher on Day 35 in the leukoreduced group, 37.9 (95% CI: 26.0, 49.8) versus 13.8 (9.4, 18.2) IU/dL. In both groups, aggregation was significantly reduced by Day 14. Thromboelastography showed remaining platelet activity on Day 35, MA 46.9 (42.1, 51.7) in the leukoreduced and 44.3 (39.6, 49.0) mm in the non-leukoreduced group. Fibrinogen was within reference ranges at Day 35 (>2 g/dL). Interleukin-6 was not detectable.
Conclusion:
Leukoreducing CPDA-1 whole blood with a platelet-saving filter did not compromise hemostatic properties. We encourage development of a single bag CPDA-1 whole blood collection set with in-line platelet-saving filter.
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