Overnight, room temperature hold of whole blood followed by 42-day storage of red blood cells in additive solution-7
Background Overnight, room temperature hold (ONH) of whole blood before component processing offers several benefits. This study evaluated the storage and in vivo recovery characteristics of ONH red blood cells (RBCs) stored in additive solution‐7 (AS‐7). Study Design and Methods We conducted a thre...
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| Veröffentlicht in: | Transfusion (Philadelphia, Pa.) Jg. 55; H. 3; S. 485 - 490 |
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United States
Blackwell Publishing Ltd
01.03.2015
Wiley Subscription Services, Inc |
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| Abstract | Background
Overnight, room temperature hold (ONH) of whole blood before component processing offers several benefits. This study evaluated the storage and in vivo recovery characteristics of ONH red blood cells (RBCs) stored in additive solution‐7 (AS‐7).
Study Design and Methods
We conducted a three‐center, three‐arm evaluation of a new blood collection system with AS‐7 compared to leukoreduced RBCs processed within 8 hours and stored in AS‐1 (control). Whole blood (500 ± 50 mL) from healthy research subjects (n = 240) was held at room temperature 0 to 2 hours, 6 to 8 hours, or ONH (18‐24 hr) before component processing and storage at 1 to 6°C. RBCs were evaluated on Days 42 and 56 with a panel of in vitro assays. Subsets of the AS‐7–stored RBCs were evaluated for 51Cr 24‐hour in vivo recovery and long‐term survival.
Results
Adenosine triphosphate (ATP) levels in ONH RBCs were not different than AS‐7 RBCs prepared within 8 hours. ATP was higher in the ONH group on Day 42 than control, and ATP was maintained in all AS‐7 groups through Day 56. ONH units had 0.36 ± 0.14% on Day 42 hemolysis (60/60 < 0.8%), and 0.54 ± 0.22% on Day 56 (10/60 > 0.8%, 2/60 > 1%). In vivo recoveries of stored RBCs were not different between the AS‐7 arms at 42 days (p = 0.16; 27/27 ONH units > 75%), but the Day 56 ONH was significantly less than ONH on Day 42 (p = 0.008; 7/28 < 75%).
Conclusions
Overnight hold of whole blood at room temperature before component processing meets current regulatory requirements when RBCs are stored up to 42 days in AS‐7. |
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| AbstractList | Background Overnight, room temperature hold (ONH) of whole blood before component processing offers several benefits. This study evaluated the storage and in vivo recovery characteristics of ONH red blood cells (RBCs) stored in additive solution-7 (AS-7). Study Design and Methods We conducted a three-center, three-arm evaluation of a new blood collection system with AS-7 compared to leukoreduced RBCs processed within 8 hours and stored in AS-1 (control). Whole blood (500±50mL) from healthy research subjects (n=240) was held at room temperature 0 to 2 hours, 6 to 8 hours, or ONH (18-24hr) before component processing and storage at 1 to 6°C. RBCs were evaluated on Days 42 and 56 with a panel of in vitro assays. Subsets of the AS-7-stored RBCs were evaluated for 51Cr 24-hour in vivo recovery and long-term survival. Results Adenosine triphosphate (ATP) levels in ONH RBCs were not different than AS-7 RBCs prepared within 8 hours. ATP was higher in the ONH group on Day 42 than control, and ATP was maintained in all AS-7 groups through Day 56. ONH units had 0.36±0.14% on Day 42 hemolysis (60/60<0.8%), and 0.54±0.22% on Day 56 (10/60>0.8%, 2/60>1%). In vivo recoveries of stored RBCs were not different between the AS-7 arms at 42 days (p=0.16; 27/27 ONH units>75%), but the Day 56 ONH was significantly less than ONH on Day 42 (p=0.008; 7/28<75%). Conclusions Overnight hold of whole blood at room temperature before component processing meets current regulatory requirements when RBCs are stored up to 42 days in AS-7. Overnight, room temperature hold (ONH) of whole blood before component processing offers several benefits. This study evaluated the storage and in vivo recovery characteristics of ONH red blood cells (RBCs) stored in additive solution-7 (AS-7).BACKGROUNDOvernight, room temperature hold (ONH) of whole blood before component processing offers several benefits. This study evaluated the storage and in vivo recovery characteristics of ONH red blood cells (RBCs) stored in additive solution-7 (AS-7).We conducted a three-center, three-arm evaluation of a new blood collection system with AS-7 compared to leukoreduced RBCs processed within 8 hours and stored in AS-1 (control). Whole blood (500 ± 50 mL) from healthy research subjects (n = 240) was held at room temperature 0 to 2 hours, 6 to 8 hours, or ONH (18-24 hr) before component processing and storage at 1 to 6 °C. RBCs were evaluated on Days 42 and 56 with a panel of in vitro assays. Subsets of the AS-7-stored RBCs were evaluated for (51) Cr 24-hour in vivo recovery and long-term survival.STUDY DESIGN AND METHODSWe conducted a three-center, three-arm evaluation of a new blood collection system with AS-7 compared to leukoreduced RBCs processed within 8 hours and stored in AS-1 (control). Whole blood (500 ± 50 mL) from healthy research subjects (n = 240) was held at room temperature 0 to 2 hours, 6 to 8 hours, or ONH (18-24 hr) before component processing and storage at 1 to 6 °C. RBCs were evaluated on Days 42 and 56 with a panel of in vitro assays. Subsets of the AS-7-stored RBCs were evaluated for (51) Cr 24-hour in vivo recovery and long-term survival.Adenosine triphosphate (ATP) levels in ONH RBCs were not different than AS-7 RBCs prepared within 8 hours. ATP was higher in the ONH group on Day 42 than control, and ATP was maintained in all AS-7 groups through Day 56. ONH units had 0.36 ± 0.14% on Day 42 hemolysis (60/60 < 0.8%), and 0.54 ± 0.22% on Day 56 (10/60 > 0.8%, 2/60 > 1%). In vivo recoveries of stored RBCs were not different between the AS-7 arms at 42 days (p = 0.16; 27/27 ONH units > 75%), but the Day 56 ONH was significantly less than ONH on Day 42 (p = 0.008; 7/28 < 75%).RESULTSAdenosine triphosphate (ATP) levels in ONH RBCs were not different than AS-7 RBCs prepared within 8 hours. ATP was higher in the ONH group on Day 42 than control, and ATP was maintained in all AS-7 groups through Day 56. ONH units had 0.36 ± 0.14% on Day 42 hemolysis (60/60 < 0.8%), and 0.54 ± 0.22% on Day 56 (10/60 > 0.8%, 2/60 > 1%). In vivo recoveries of stored RBCs were not different between the AS-7 arms at 42 days (p = 0.16; 27/27 ONH units > 75%), but the Day 56 ONH was significantly less than ONH on Day 42 (p = 0.008; 7/28 < 75%).Overnight hold of whole blood at room temperature before component processing meets current regulatory requirements when RBCs are stored up to 42 days in AS-7.CONCLUSIONSOvernight hold of whole blood at room temperature before component processing meets current regulatory requirements when RBCs are stored up to 42 days in AS-7. Background Overnight, room temperature hold (ONH) of whole blood before component processing offers several benefits. This study evaluated the storage and in vivo recovery characteristics of ONH red blood cells (RBCs) stored in additive solution‐7 (AS‐7). Study Design and Methods We conducted a three‐center, three‐arm evaluation of a new blood collection system with AS‐7 compared to leukoreduced RBCs processed within 8 hours and stored in AS‐1 (control). Whole blood (500 ± 50 mL) from healthy research subjects (n = 240) was held at room temperature 0 to 2 hours, 6 to 8 hours, or ONH (18‐24 hr) before component processing and storage at 1 to 6°C. RBCs were evaluated on Days 42 and 56 with a panel of in vitro assays. Subsets of the AS‐7–stored RBCs were evaluated for 51Cr 24‐hour in vivo recovery and long‐term survival. Results Adenosine triphosphate (ATP) levels in ONH RBCs were not different than AS‐7 RBCs prepared within 8 hours. ATP was higher in the ONH group on Day 42 than control, and ATP was maintained in all AS‐7 groups through Day 56. ONH units had 0.36 ± 0.14% on Day 42 hemolysis (60/60 < 0.8%), and 0.54 ± 0.22% on Day 56 (10/60 > 0.8%, 2/60 > 1%). In vivo recoveries of stored RBCs were not different between the AS‐7 arms at 42 days (p = 0.16; 27/27 ONH units > 75%), but the Day 56 ONH was significantly less than ONH on Day 42 (p = 0.008; 7/28 < 75%). Conclusions Overnight hold of whole blood at room temperature before component processing meets current regulatory requirements when RBCs are stored up to 42 days in AS‐7. Overnight, room temperature hold (ONH) of whole blood before component processing offers several benefits. This study evaluated the storage and in vivo recovery characteristics of ONH red blood cells (RBCs) stored in additive solution-7 (AS-7). We conducted a three-center, three-arm evaluation of a new blood collection system with AS-7 compared to leukoreduced RBCs processed within 8 hours and stored in AS-1 (control). Whole blood (500 ± 50 mL) from healthy research subjects (n = 240) was held at room temperature 0 to 2 hours, 6 to 8 hours, or ONH (18-24 hr) before component processing and storage at 1 to 6 °C. RBCs were evaluated on Days 42 and 56 with a panel of in vitro assays. Subsets of the AS-7-stored RBCs were evaluated for (51) Cr 24-hour in vivo recovery and long-term survival. Adenosine triphosphate (ATP) levels in ONH RBCs were not different than AS-7 RBCs prepared within 8 hours. ATP was higher in the ONH group on Day 42 than control, and ATP was maintained in all AS-7 groups through Day 56. ONH units had 0.36 ± 0.14% on Day 42 hemolysis (60/60 < 0.8%), and 0.54 ± 0.22% on Day 56 (10/60 > 0.8%, 2/60 > 1%). In vivo recoveries of stored RBCs were not different between the AS-7 arms at 42 days (p = 0.16; 27/27 ONH units > 75%), but the Day 56 ONH was significantly less than ONH on Day 42 (p = 0.008; 7/28 < 75%). Overnight hold of whole blood at room temperature before component processing meets current regulatory requirements when RBCs are stored up to 42 days in AS-7. |
| Author | Maes, Lou Ann Cancelas, Jose A. Hess, John R. Szczepiorkowski, Zbigniew M. Zia, Majid Dumont, Larry J. Whitley, Pamela Siegal, Alan H. Herschel, Louise Rugg, Neeta |
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| References | Jenkins C, Ramirez-Arcos S, Goldman M, et al. Bacterial contamination in platelets: incremental improvements drive down but do not eliminate risk. Transfusion 2011;51:2555-2565. Shinar E, Etlin S. Frendel O, Yahalom V. The implementation of rapid cooling and overnight hold of whole blood at ambient temperature before processing into components in Israel. Transfusion 2011;51:58S-64S. Thomas S. Ambient overnight hold of whole blood prior to the manufacture of blood components. Transfus Med 2010;20:361-368. Hess JR, Rugg N, Joines AD, et al. Buffering and dilution in red blood cell storage. Transfusion 2006;46:50-54. Dumont LJ, Cancelas JA, Maes LA, et al. The bioequivalence of frozen plasma prepared from whole blood held overnight at room temperature compared to fresh-frozen plasma prepared within eight hours of collection. Transfusion 2014. doi: 10.1111/trf.12864. Cancelas JA, Dumont LJ, Maes LY, et al. Additive solution-7 reduces the red blood cell cold storage lesion. Transfusion 2014. doi: 10.1111/trf.12867. Hogman CF, Engstrand L. Factors affecting growth of Yersinia enterocolitica in cellular blood products. Transfus Med Rev 1996;10:259-275. Levin E, Culibrk B, Gyongyossy-Issa MIC, et al. Implementation of buffy coat platelet component production: comparison to platelet-rich plasma platelet production. Transfusion 2008;48:2331-2337. Hess JR. An update on solutions for red cell storage. Vox Sang 2006;91:13-19. Pietersz RNJ. Storage of whole blood for up to 24 hours at ambient temperature before component preparation: implementation in the Netherlands. Transfusion 2011;51:3S-6S. 2008; 48 2006; 91 2010; 20 2014 2006; 46 1996; 10 2011; 51 e_1_2_8_3_1 e_1_2_8_2_1 e_1_2_8_5_1 e_1_2_8_4_1 e_1_2_8_7_1 e_1_2_8_6_1 e_1_2_8_9_1 e_1_2_8_8_1 e_1_2_8_10_1 e_1_2_8_11_1 25759126 - Transfusion. 2015 Mar;55(3):463-5 |
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Overnight, room temperature hold (ONH) of whole blood before component processing offers several benefits. This study evaluated the storage and in... Overnight, room temperature hold (ONH) of whole blood before component processing offers several benefits. This study evaluated the storage and in vivo... Background Overnight, room temperature hold (ONH) of whole blood before component processing offers several benefits. This study evaluated the storage and in... |
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| SubjectTerms | Adenine - pharmacology Adenosine Triphosphate - blood Blood Preservation - methods Buffers Cell Survival Citrates - pharmacology Erythrocytes - cytology Erythrocytes - drug effects Glucose - pharmacology Hematocrit Humans Hydrogen-Ion Concentration In Vitro Techniques Leukocyte Reduction Procedures - instrumentation Mannitol - pharmacology Osmolar Concentration Pharmaceutical Solutions - pharmacology Sodium Chloride - pharmacology Temperature Time Factors |
| Title | Overnight, room temperature hold of whole blood followed by 42-day storage of red blood cells in additive solution-7 |
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