?@$AB -...

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#!$" H¡37lzcW=ª,2}WRz cW£(Erythrocytapheresis$RBCa)59:}W Rz(RBC) 2 C(<-_6 4 C)cn +;,7 RBC 4z(W´§7Wt)46 jcn-/11+: 1) 2) !2'3 [57}W RL¢°6 20* T.- RBCa 59;46©8 +; 3) " % & }WRzcW5O0;Y \ 1) x 2) m ]q 3) ~ Pw 4) ®N V 5) tv 6) 1) {y s 7) 1) ¥K}piWG>@?% 2) AZ}piWG>@?% 3) e}piWG>@?% 4) IZ}piWG>@?% 5) S-U`E¨W#d¤k¯J 6) SDJhJM(rgF«M²u|¬M^b) 7) B±M²uYaDM^b ( z 17 6 X 21 o) ( z 17 10 X 3 o¬) FEASIBILITY AND SAFETY OF RED CELL COLLECTION BY APHERESIS TECHNOLOGY Sadamitsu Yamamoto 1) , Tadashi Kamiya 2) , Hitoshi Shibata 3) , Yoshiaki Maeda 4) , Kiyoshi Hiruma 5) , Fumio Komatsu 6) , Hisami Ikeda 1) and Masaru Shimizu 7) 1) Hokkaido Red Cross Blood Center, 2) Aichi Red Cross Blood Center, 3) Osaka Red Cross Blood Center, 4) Fukuoka Red Cross Blood Center, 5) Department of Clinical physiology. Kagawa Nutrition University, 6) Division of Transfusion and Cell Therapy. Tokyo Metropolitan Hospital, 7) Department of Clinical Pathology. Kyorin University School of Medicine. We evaluated the feasibility and safety of red cell collection by apheresis technology. Red cells corresponding to 600 ml of whole blood were collected with two types of apheresis machine(Trima and CCS) . Healthy male donors whose (circulating) blood volume was 4,100 ml or more were entered into the trial. Mean time for the entire process was 32.4 min. All procedures were completed without interruption, although one case of vaso-vagal reaction was noted during collection. No sign of serious side effects was reported after collection. Red cell counts and hemoglobin values of the donors recov- ered to the baseline 2-3 months after collection, although serum ferritin remained at 64.4* of pre- donation values after 6 months. It was concluded that red cell collection by apheresis technology equivalent to 600 ml of whole blood is feasible and safe. However, a large scale clinical trial will be necessary to affirm the safety of this procedure. erythrocytapheresis, apheresis, red cell concentrates, adverse reaction, quality of blood components Key words$ Japanese Journal of Transfusion Medicine, Vol. 52. No. 1 52 (1)$44&51, 2006

Transcript of ?@$AB -...

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FEASIBILITY AND SAFETY OF RED CELL COLLECTION BY APHERESIS TECHNOLOGY

Sadamitsu Yamamoto1�, Tadashi Kamiya2�, Hitoshi Shibata3�, Yoshiaki Maeda4�,Kiyoshi Hiruma5�, Fumio Komatsu6�, Hisami Ikeda1�and Masaru Shimizu7�

1�Hokkaido Red Cross Blood Center, 2�Aichi Red Cross Blood Center, 3�Osaka Red Cross Blood Center,4�Fukuoka Red Cross Blood Center, 5�Department of Clinical physiology. Kagawa Nutrition University,

6�Division of Transfusion and Cell Therapy. Tokyo Metropolitan Hospital,7�Department of Clinical Pathology. Kyorin University School of Medicine.

We evaluated the feasibility and safety of red cell collection by apheresis technology. Red cellscorresponding to 600 ml of whole blood were collected with two types of apheresis machine�Trimaand CCS�. Healthy male donors whose�circulating�blood volume was 4,100 ml or more were enteredinto the trial. Mean time for the entire process was 32.4 min. All procedures were completed withoutinterruption, although one case of vaso-vagal reaction was noted during collection. No sign of seriousside effects was reported after collection. Red cell counts and hemoglobin values of the donors recov-ered to the baseline 2-3 months after collection, although serum ferritin remained at 64.48 of pre-donation values after 6 months.

It was concluded that red cell collection by apheresis technology equivalent to 600 ml of wholeblood is feasible and safe. However, a large scale clinical trial will be necessary to affirm the safety ofthis procedure.

erythrocytapheresis, apheresis, red cell concentrates, adverse reaction, quality of bloodcomponents

Key words�

Japanese Journal of Transfusion Medicine, Vol. 52. No. 1 52�1��44�51, 2006

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Table 1 Characteristics of blood donors and collection conditions for the two types of apheresis machine.

Mean±SD(Min―Max)

p value(Trimavs. CCS)

CCS(n=21)Trima(n=16)Total(n=37)

NS(22―54)34.9±8.4(22―56)36.0±10.5(22―56)35.4±9.3Age

NS(165―185)171.5±5.1(162―180)173.4±5.3(162―185)172.3±5.2Height(cm)

NS(58―82)67.5±8.1(62―82)69.0±5.9(58―82)68.1±7.2Weight(Kg)

NS(4,169―5,607)4,667±465(4,257―5,413)4,768±288(4,169―5,607)4,711±396CBV(ml)

NS(13.9―16.6)15.3±0.8(14.0―17.0)15.6±0.7(13.9―17.0)15.4±0.8Hb(g/dL)

NS(43.1―50.1)45.5±2.0(40.6―48.4)45.3±2.4(40.6―50.1)45.5±2.1Ht(%)

NS(461―557)495.8±26.8(408―540)494.4±32.4(408―557)495.2±28.9RBC(104/μ L)

NS(3,600―9,800)5,970±1,900(4,000―9,300)5,640±1,490(3,600―9,800)5,820±1,720WBC(/μ L)

NS(14.0―33.4)23.5±5.1(11.3―33.6)22.5±5.4(11.3―34.4)23.0±5.2PLT(104/μ L)

p<0.01(9.6―14.7)12.5±1.3(9.8―12.5)11.1±0.7(9.6―14.7)11.9±1.3Max. ECBV/CBV(%)

p<0.01(5.6―7.5)6.7±0.6(5.5―7.0)6.2±0.7(5.5―7.5)6.5±0.5Collection Volume/CBV(%)

p<0.01(31―48)36.9±0.6(23―35)26.5±3.9(23―48)32.4±6.4N-N time(min)

CBV:circulating blood volume

ECVB:extracorporeal CBV

N-N time:from insertion to withdrawal of needle

NS:not significant

Table 2 Adverse reactions during and after red cell apheresis.

SymptomsType**Hb reductionafter collection

CBV(ml) *Case No.(#)

【During and immediately after collection】

VVR***(grade1)C2.64.4#1

mild citrate reaction with sweating and chest tightnessT2,C61.6―2.34.2―5.4#2―9

【Up to 1 week after collection】

headache resolved after return homeC1.74.9#10

heavy feeling in the head, dullness and faintness lasting one dayT1.14.6#11

heavy feeling in the head resolved after return homeC0.94.8#12

heavy feeling in the head lasting one dayC2.24.3#13

dullness lasting a few daysC1.54.2#14

*CBV:circulating blood volume **C:CCS, T:Trima ***VVR:vasovagal reaction

3�Fig. 1����Hb�� Ht�� RBC�� ������� 87.5�87.8��������3���� 98�99���������������� �� Hb��� !��"!��#$%�&�'Fig. 2(�)*�+,-, 1.92.0.17g�dl�1.97.0.52g�dl���/0�12�3�45�6789#:;�<=��>?���� 2�3@��1AB�� Hb��� !��"!��B�C89�<=�'DEFG�HI(�J���� Hb�K&2 CBV��� �� HbLMN��B�C89�<=���O�1AB�� Hb��N

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46 Japanese Journal of Transfusion Medicine, Vol. 52. No. 1

Fig. 1 Changes in hematologic values in blood donors before and after red cell

apheresis.

Fig. 2 Relationship between estimated reduction of

Hb concentration and actual reduction immediately

after red cell apheresis.

12�14��2g�dl����� 18� 1�6�� � 13�������������� Hb�� 2.9g�dl����� ��!��"! Hb�� 15.9g�dl�CBV� 4,300ml#$ 165cm�%& 62kg����'! CBV(� 7.3���)�1*+�! Hb�� 13.9g�dl��"�,-!./0 87.4����������1��,- 1*+2�!34�5�67��,���

89�400ml:��� 21��! Hb!;<=>�� 1.3?0.1g�dl�����!@>�� 0.4?0.4g�dlA0.7B0.8g�dl��2B3C�!DE� 0.9?0.6g�dlA0.1B2.1g�dl���=>��@>���FG��H�:��� 6IJ+!34KL�MCV�MCH�MCHC!MNOPQRS�,���s-Fe!T;��8U!VWORSX,���Y

9�TIBC������ZZ;<93.0�� ���1B2*+���"�O[7�1B2IJ���\107.1����)�4IJ���"��]��Fig.1��free-EPO��� 1*+��^T _�\158.5����)���`; _ 3IJ����ab"�����Fig. 1��cEO����! Hb��� 2g�dl���de!f��(ghi��2g�dl����� 1*+�� 162.5���de�!155.9��(g _ZZj,���!!�f�+�klm�RS�,���s-Ft� 1*+��"�! 64.8�������1

IJ��� 45.0�����On �6IJ���

Cop�qrst u52v u 1w 47

Table 3 Changes in hematologic values in blood donors before and after red cell apheresis.

6 months

3 months

1 month

1 week

0 day

before

Laboratory items

p value

NMean±SD

p value

NMean±SD

p value

NMean±SD

p value

NMean±SD

p value

NMean±SD

NMean±SD

NS

37479.9±29.2

NS

37488.4±26.4

*<.001

37470.0±25.9

*<.001

37447.0±28.7

*<.001

37433.2±30.6

37495.2±28.9

RBC

(×104 /μl)

97.0±4.9

98.7±3.6

95.0±3.8

90.3±3.9

87.5±3.4

100.0±

(%)

NS

37 44.6±2.6

NS

37 44.9±1.9

*<.001

37 43.8±2.0

*<.001

37 41.2±2.1

*<.001

37 39.9±2.5

37 45.5±2.1

Ht

(%)

98.1±5.4

98.8±3.5

96.4±4.0

90.6±3.4

87.8±3.7

100.0±

(%)

NS

37 15.1±0.8

NS

37 15.1±0.8

*<.001

37 14.7±0.7

*<.001

37 13.9±0.8

*<.001

37 13.5±0.9

37 15.4±0.8

Hb

(g/dl)

98.4±6.2

98.0±4.8

95.6±4.2

90.3±3.9

87.6±3.4

100.0±

(%)

NS

37 93.0±3.8

NS

37 92.0±3.7

NS

37 93.1±3.7

NS

37 92.2±3.4

NS

37 92.2±3.1

37 91.9±3.2

MCV (fl)

101.2±2.6

100.2±1.6

101.4±1.8

100.4±2.0

100.4±0.7

100.0±

(%)

NS

37 31.5±1.6

NS

37 30.9±1.8

NS

37 31.2±1.7

NS

37 31.1±1.5

NS

37 31.2±1.6

37 31.1±1.6

MCH (pg)

101.4±2.8

99.3±3.1

100.4±2.6

100.0±1.9

100.2±1.3

100.0±

(%)

NS

37 33.9±1.4

NS

37 33.3±2.3

NS

37 33.6±1.5

NS

37 33.8±1.4

NS

37 33.7±1.5

37 33.9±1.3

MCHC (%)

100.2±3.0

98.4±6.3

99.1±3.6

99.8±2.1

99.5±2.2

100.0±

(%)

NS

31110.7±38.9

NS

31100.3±36.8

NS

31 78.4±33.0

NS

31 98.4±37.2

NS

25 87.4±31.0

31 99.7±35.3

s-Fe

(μg/dl)

127.1±74.7

112.4±62.0

90.7±52.9

111.3±57.0

91.0±8.5

100.0±

(%)

NS

31327.2±35.3

NS

31344.6±41.5

*<.001

31352.9±37.5

NS

31335.1±37.0

NS

25311.3±27.5

31330.0±33.4

TIBC (μg/dl)

99.4±8.3

104.5±7.6

107.1±5.0

101.6±5.7

93.0±4.1

100.0±

(%)

NS

31 68.8±64.7

NS

31 60.0±60.3

*<.001

31 59.4±72.5

NS

31 84.1±94.6

――

―±―

31116.1±97.7

s-Ft

(ng/ml)

64.4±25.5

49.7±18.2

45.0±14.1

64.8±18.3

――

―±―

100.0±

(%)

NS

31 18.1±4.7

NS

31 18.1±4.5

*<.001

31 21.3±6.4

*<.001

31 28.1±7.7

――

―±―

31 18.3±4.7

freeEPO (mU/ml)

102.0±28.5

101.2±23.2

118.4±27.7

158.5±41.1

――

―±―

100.0±

(%)

NS

37 57.1±14.9

NS

37 56.6±16.7

NS

37 56.2±15.8

NS

37 58.7±16.8

NS

37 53.1±16.5

37 58.2±17.2

WBC (×102 /μl)

101.1±20.2

99.0±18.2

98.7±18.4

103.2±21.4

91.0±8.7

100.0±

(%)

NS

37 23.5±4.6

NS

37 22.8±4.7

NS

37 23.8±5.5

NS

37 25.7±5.6

NS

37 22.8±5.1

37 23.0±5.2

PLT (×104 /μl)

103.8±15.3

100.3±12.9

104.1±14.8

112.7±13.3

99.4±7.1

100.0±

(%)

s-Fe:serum iron, s-Ft:serum ferritin, free-EPO:free erythropoietin

48 Japanese Journal of Transfusion Medicine, Vol. 52. No. 1

Table 4 Characteristics of red cell concentrates on the day collected by red cell apheresis.

CCS(n=21)Trima(n=16)TotalParameter

442.5±22.2455.0±11.5448.3±15.3Volume#(ml)

57.1±3.150.9±3.954.4±4.6Ht(%)

19.1±0.717.6±1.518.5±1.3Hb(g/dl)

84.3±5.878.3±6.481.7±6.7Total Hb(g/bag)

2.7±0.1 2.4±0.2 2.6±0.2Total RBC(×1012/bag)

1.5±0.7 0.9±0.6 1.3±0.8Total WBC(×109/bag)

2.7±3.6 1.7±1.4 2.3±2.6Total platelets(×1010/bag)

4.3±0.6 4.2±0.5 4.3±0.6ATP(μMol/gHb)

11.7±0.911.2±1.611.5±1.32.3-DPG(μMol/gHb)

41.0±21.1 37.5±28.1 39.1±25.2free-Hb(mg/dl)

#:additive solution included *:P<0.01

Cf.free Hb in MAP-added RCC derived from 400 ml whole blood is 8 mg/dl.

Fig. 3 Changes in free hemoglobin levels in super-

natants of red cell concentrates during storage.

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����CCS��WBC& PLT�MA�..S012�3��Table 4��K�L� pH�ATP�2,3-DPG�TUFGV

400mlW�XY�MAPZ RCC�400RCC�&[\]^&�7_`ab��cd<=�12�3�����e ��fg�hi Hb���OPQ 37.5mg�dl�CCS 41.1mg�dl&�400RCC� 8.0mg�dl�[�jAkl��3'�abg:cdmn�j�o��Fig. 3���e 4* 3_`p� q��hi Hb��rZ-��OPQ 129.6��CCS256.3��400RCC 352.0��3s7_ �̀ q��t

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