Scientific problems in the regulation of red blood cell products

@article{Hess2012ScientificPI,
  title={Scientific problems in the regulation of red blood cell products},
  author={John R Hess},
  journal={Transfusion},
  year={2012},
  volume={52}
}
  • J. Hess
  • Published 2012
  • Medicine
  • Transfusion
BACKGROUND: For the past 30 years, red blood cell (RBC) storage systems have been licensed in the United States based on the demonstration that 24‐hour in vivo recovery was greater than 75% and hemolysis was less than 1%. Now additional requirements for storage system licensure have being added. The meaning and value of these new requirements have been questioned. 

Paper Mentions

Interventional Clinical Trial
The purpose of the study is to determine the safety of pooled red blood cells (RBCs) compared to standard leukoreduced RBC products stored in additive solution. The primary objective is… Expand
ConditionsAnemia, Transfusion Reaction
InterventionBiological
Red blood cell in vitro quality and function is maintained after S‐303 pathogen inactivation treatment
TLDR
The S‐303 system has been shown to effectively inactivate a broad spectrum of pathogens, while maintaining RBC quality. Expand
The heritability of metabolite concentrations in stored human red blood cells
TLDR
In a classic twin study, the heritability of poststorage ATP concentrations is confirmed and many other RBC metabolites are established, including those of EMTs, which are a major issue in transfusion medicine. Expand
The pathophysiology and consequences of red blood cell storage
TLDR
An in‐depth overview of the pathophysiological mechanisms underlying red cell storage is presented, with a focus on altered metabolism, oxidative stress and red cell membrane damage. Expand
Washing stored red blood cells in an albumin solution improves their morphologic and hemorheologic properties
TLDR
Investigation of the impact of progressive echinocytic shape recovery on biorheologic variables in red blood cells storage lesions finds that it can be partially reversed by washing in albumin solutions. Expand
Red Blood Cell Products
TLDR
Red blood cell products are produced primarily from whole blood units, but may also be collected by apheresis, and can be modified by leukoreduction, irradiation, and washing to meet the needs of patients. Expand
Similar donors—similar blood?
TLDR
This study evaluates interdonor versus intradonor variability, throughout storage, of both MF and autohemolysis (AH) in red blood cell storage lesions. Expand
Time to revisit red blood cell additive solutions and storage conditions: a role for "omics" analyses.
  • R. Sparrow
  • Medicine
  • Blood transfusion = Trasfusione del sangue
  • 2012
TLDR
This perspectives paper will provide a brief overview of the currently licensed RBC additive solutions, new experimental additive Solutions, some of the challenges for progressing the development of RBC storage systems and where the application of “omics” analyses could benefit the advancement of R BC storage systems. Expand
Does prolonged storage of red blood cells cause harm?
TLDR
Institutions involved in blood collection and transfusion should explore strategies that assure blood availability, while limiting the use of the oldest RBCs currently approved by regulation. Expand
Donor variation effect on red blood cell storage lesion: a multivariable, yet consistent, story
TLDR
This study was conducted to evaluate whether variation in hemolysis, microparticle accumulation, phosphatidylserine exposure, and other storage lesion–associated variables might be a function of the prestorage hematologic and biologic profiles of the donor. Expand
Assessing the influence of component processing and donor characteristics on quality of red cell concentrates using quality control data
TLDR
Analysis of quality control data can be used to highlight the sources of variability within red cell concentrates (RCCs) and to ensure compliance with regulatory standards. Expand
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References

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An update on solutions for red cell storage
  • J. Hess
  • Biology, Medicine
  • Vox sanguinis
  • 2006
TLDR
Improved scientific understanding of the red cell storage lesion has shown a way to make even better storage solutions, which maintain red cell metabolism and reduce membrane loss. Expand
BLOOD COMPONENTS: Red blood cell hemolysis during blood bank storage: using national quality management data to answer basic scientific questions
TLDR
Hemolysis of red blood cells during blood bank storage is the most obvious manifestation of RBC storage system failure, but its analysis is made difficult because the largest source of interunit difference is donor specific. Expand
Evaluation of proposed FDA criteria for the evaluation of radiolabeled red cell recovery trials
TLDR
The ability of currently available RBC systems to satisfy the most recently proposed criteria for recovery of radiolabeled red blood cells 24 hours after autologous reinfusion in normal subjects was defined. Expand
Buffering and dilution in red blood cell storage
BACKGROUND:  Red blood cell (RBC) storage solutions work in a narrow pH range between 7.2 and 6.4. While keeping RBC within that pH range, ATP production can be increased by buffering or dilution.
Proposed standardization of methods for determining the 24‐hour survival of stored red cells
TLDR
Two methods of determining the survival of stored red cells are described: one using a double label and one usingA single label in the hope that the personnel of laboratories engaged in determining the effectiveness of anticoagulant‐preservation will follow one of the protocols presented. Expand
The viability of autologous human red cells stored in additive solution 5 and exposed to 25°C for 24 hours
TLDR
This data indicates that red cells storsed in modern additive solution systems and allowed to warm above 10°C have low viability and should be removed from the additive solution system. Expand
Interlaboratory comparison of red‐cell ATP, 2,3‐diphosphoglycerate and haemolysis measurements
TLDR
The reproducibility of RBC ATP, DPG and haemolysis measurements between centres was investigated and it was found that red blood cell storage systems are licensed based on their ability to prevent haenolysis and maintain RBC 24‐h in vivo recovery. Expand
Effect of prophylactic transfusion of stored RBCs on oxygen reserve in response to acute isovolemic hemorrhage in a rodent model
TLDR
The objective of this study was to compare the effect that transfusion of stored 2,3 DPG‐depleted rat blood had on the O2 reserve in conscious rats, with that of the transfusions of fresh blood (<2‐hour storage. Expand
Antibodies provoked by the transfusion of biotin‐labeled red cells
TLDR
This work has shown that Biotin‐labeled (biotinylated) red cells (B‐RBCs) offer a technique by which to study RBC volume and circulating kinetics without in vivo radiation. Expand
Comparative Viability of Blood Stored in ACD and CPD
TLDR
Neither early recovery, 24‐hour survival, nor t/2 could be shown to correlate with pH, plasma potassium, plasma sodium, per cent hemolysis, and osmotic fragility, which point out the need for greater number of observations with increasing duration of storage for adequate appraisal of blood preservative solutions. Expand
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