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Quality, stability, and safety data of packed red cells and plasma processed by gravity separation using a new fully integrated hollow-fibre filter device.

Brune T, Hannemann-Pohl K, Nißle K, Ecker N, Garritsen H - Adv Hematol (2010)

Bottom Line: Furthermore the cost-effectiveness of this hollow fibre system was evaluated.Results were compared to 15 whole blood preparations using centrifugation.Conclusion.

View Article: PubMed Central - PubMed

Affiliation: University Children's Hospital, Gerhart-Hauptmann- Strasse 35, 39108 Magdeburg, Germany.

ABSTRACT
Background. We developed a completely closed system based on gravity separation without centrifugation steps for separation of whole blood. With this new system we compared quality and stability of the processed blood components (PRC and plasma) with respect to classical preparation. Furthermore the cost-effectiveness of this hollow fibre system was evaluated. Study Design and Methods. Whole blood collections of 15 regular blood donors were used for component preparation using the U shaped hollow fibre filter device. Results were compared to 15 whole blood preparations using centrifugation. The following parameters were evaluated: total hemoglobin, leukocyte counts, the serum concentration of total protein, lactate dehydrogenase (LDH) and potassium. Furthermore ATIII, vWF and F VIII were analyzed at different timepoints. Results. packed red cells: the data directly after separation and after 42 days of storage are in line with the guidelines of the council of Europe. Plasma. all plasma quality data are in line with the guidelines of the council of Europe for quality assurance of plasma, except for a low protein amount (factor 0.75). Conclusion. Separation of whole blood on a clinical scale in this new closed system is feasible, however the plasma protein content must be optimized.

No MeSH data available.


Related in: MedlinePlus

Complete gravity-separation system. (a) Donation bag prefilled with 63 mL CPD, (b) Mean stand, (c) Erythrocyte bag prefilled with 100 mL extended storage medium (PAGGS-M), (d) Hollow-fibre filter, (e) Leukocyte filter, (f) Plasma bag.
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fig2: Complete gravity-separation system. (a) Donation bag prefilled with 63 mL CPD, (b) Mean stand, (c) Erythrocyte bag prefilled with 100 mL extended storage medium (PAGGS-M), (d) Hollow-fibre filter, (e) Leukocyte filter, (f) Plasma bag.

Mentions: Before blood separation the donated whole blood unit was left to rest at ambient temperature (about 20°C) for 2 hours in order to allow phagocytosis for free bacteria. The details of the closed hollow-fibre separation system are given in Figure 2. The gravity-separation procedure is performed as follows. First the donation bag containing 63 mL CPD (1000 mL of CPD contains 3.27 g of citric acid·H2O, 26.3 g of sodium citrate·2H2O, 25.5 g of glucose·H2O, and 2.51 g of NaH2PO4·H2O) is hung on the upper hook of the main stand (b). Then the packed red cells (PRCs) bag (c) prefilled with extended storage medium (100 mL PAGGS-M) (1000 mL of PAGGS-M contains 9.400 g of glucose·H2O, 1.255 g of NaH2PO4·H2O, 1.432 g of NaHPO4·H2O, 0.194 g of adenine, 0.408 g of guanosine, 10.000 g of mannitol and 4.210 g of sodium chloride) and the separation filter (d) is hung on the middle attachments both exactly on the same level. After all clamps and inline break valves have been opened the blood flows from the donation bag through the leukocyte filter (e) and subsequently into the hollow-fibre system. While the leukocyte-depleted blood is slowly running through the inner space of the U-shaped hollow fibres the plasma is diffusing through the porous walls with the result that the blood is separated into plasma and erythrocytes. The blood flow can be regulated via a roller clamp, and the flow rate was regulated via a drip chamber. The cell-free plasma flows down into the plasma bag (f) and the erythrocytes to the erythrocytes bag. After approximately 40 minutes the separation is finished. After completion of the separation the PRC bag and the plasma bag were sealed and disconnected from the separation set. All plasma preparations were frozen immediately and stored at −30°C (Blood Plasma Freezer: UF 40-300S, Colora GmbH, Lorch, Germany). For quality control testing of the PRCs we performed an automatic blood cell count and the free hemoglobin concentration was measured. The hemolysis rate was calculated according to the formula (100 – Hct) × free HB/Hb. After processing the 15 PRCs were stored for 42 days at +4°C in a regular blood bank refrigerator (Blood Bank Refrigerator BL-720, Philipp Kirsch GmbH, Offenburg, Germany) After 42 days of storage all quality controls described above were repeated in the PRCs and sterility control was performed. For quality control testing of the plasma, concentrations of total protein, LDH, potassium and fibrinogen and also the residual leukocytes count were performed. In addition, the activity of the coagulation factors AT III, vWF, and F VIII was determined. The plasma was frozen at −30°C according to a standard protocol. After 366 days of storage the frozen plasma was thawed and F VIII activity was measured again.


Quality, stability, and safety data of packed red cells and plasma processed by gravity separation using a new fully integrated hollow-fibre filter device.

Brune T, Hannemann-Pohl K, Nißle K, Ecker N, Garritsen H - Adv Hematol (2010)

Complete gravity-separation system. (a) Donation bag prefilled with 63 mL CPD, (b) Mean stand, (c) Erythrocyte bag prefilled with 100 mL extended storage medium (PAGGS-M), (d) Hollow-fibre filter, (e) Leukocyte filter, (f) Plasma bag.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2821640&req=5

fig2: Complete gravity-separation system. (a) Donation bag prefilled with 63 mL CPD, (b) Mean stand, (c) Erythrocyte bag prefilled with 100 mL extended storage medium (PAGGS-M), (d) Hollow-fibre filter, (e) Leukocyte filter, (f) Plasma bag.
Mentions: Before blood separation the donated whole blood unit was left to rest at ambient temperature (about 20°C) for 2 hours in order to allow phagocytosis for free bacteria. The details of the closed hollow-fibre separation system are given in Figure 2. The gravity-separation procedure is performed as follows. First the donation bag containing 63 mL CPD (1000 mL of CPD contains 3.27 g of citric acid·H2O, 26.3 g of sodium citrate·2H2O, 25.5 g of glucose·H2O, and 2.51 g of NaH2PO4·H2O) is hung on the upper hook of the main stand (b). Then the packed red cells (PRCs) bag (c) prefilled with extended storage medium (100 mL PAGGS-M) (1000 mL of PAGGS-M contains 9.400 g of glucose·H2O, 1.255 g of NaH2PO4·H2O, 1.432 g of NaHPO4·H2O, 0.194 g of adenine, 0.408 g of guanosine, 10.000 g of mannitol and 4.210 g of sodium chloride) and the separation filter (d) is hung on the middle attachments both exactly on the same level. After all clamps and inline break valves have been opened the blood flows from the donation bag through the leukocyte filter (e) and subsequently into the hollow-fibre system. While the leukocyte-depleted blood is slowly running through the inner space of the U-shaped hollow fibres the plasma is diffusing through the porous walls with the result that the blood is separated into plasma and erythrocytes. The blood flow can be regulated via a roller clamp, and the flow rate was regulated via a drip chamber. The cell-free plasma flows down into the plasma bag (f) and the erythrocytes to the erythrocytes bag. After approximately 40 minutes the separation is finished. After completion of the separation the PRC bag and the plasma bag were sealed and disconnected from the separation set. All plasma preparations were frozen immediately and stored at −30°C (Blood Plasma Freezer: UF 40-300S, Colora GmbH, Lorch, Germany). For quality control testing of the PRCs we performed an automatic blood cell count and the free hemoglobin concentration was measured. The hemolysis rate was calculated according to the formula (100 – Hct) × free HB/Hb. After processing the 15 PRCs were stored for 42 days at +4°C in a regular blood bank refrigerator (Blood Bank Refrigerator BL-720, Philipp Kirsch GmbH, Offenburg, Germany) After 42 days of storage all quality controls described above were repeated in the PRCs and sterility control was performed. For quality control testing of the plasma, concentrations of total protein, LDH, potassium and fibrinogen and also the residual leukocytes count were performed. In addition, the activity of the coagulation factors AT III, vWF, and F VIII was determined. The plasma was frozen at −30°C according to a standard protocol. After 366 days of storage the frozen plasma was thawed and F VIII activity was measured again.

Bottom Line: Furthermore the cost-effectiveness of this hollow fibre system was evaluated.Results were compared to 15 whole blood preparations using centrifugation.Conclusion.

View Article: PubMed Central - PubMed

Affiliation: University Children's Hospital, Gerhart-Hauptmann- Strasse 35, 39108 Magdeburg, Germany.

ABSTRACT
Background. We developed a completely closed system based on gravity separation without centrifugation steps for separation of whole blood. With this new system we compared quality and stability of the processed blood components (PRC and plasma) with respect to classical preparation. Furthermore the cost-effectiveness of this hollow fibre system was evaluated. Study Design and Methods. Whole blood collections of 15 regular blood donors were used for component preparation using the U shaped hollow fibre filter device. Results were compared to 15 whole blood preparations using centrifugation. The following parameters were evaluated: total hemoglobin, leukocyte counts, the serum concentration of total protein, lactate dehydrogenase (LDH) and potassium. Furthermore ATIII, vWF and F VIII were analyzed at different timepoints. Results. packed red cells: the data directly after separation and after 42 days of storage are in line with the guidelines of the council of Europe. Plasma. all plasma quality data are in line with the guidelines of the council of Europe for quality assurance of plasma, except for a low protein amount (factor 0.75). Conclusion. Separation of whole blood on a clinical scale in this new closed system is feasible, however the plasma protein content must be optimized.

No MeSH data available.


Related in: MedlinePlus