Paired comparison of methylene blue‐ and amotosalen‐treated plasma and cryoprecipitate

Backholer, Lucy; Wiltshire, Michael; Proffitt, Susan; Cookson, P.; Cardigan, Rebecca

doi:10.1111/vox.12368

Cited by 16 publications

(19 citation statements)

References 20 publications

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“…The authors noted that the mean values for all 18 plasma protein activities tested fell within normal references ranges in all cases and that ADAMTS-13 was unaffected by either PR treatment [84]. Backholer et al reported similar findings in another paired comparison in which FV, FXI, FXIII, and fibrinogen losses were significant for MB-FFP, but not for AS-FFP, by analysis of variation (ANOVA) of FFP, MB-FFP, and AS-FFP; six other coagulation factors were unaffected by either treatment [85]. Cardigan et al noted reductions of 10% in ETP and 30% in peak thrombin in thrombin generation assays of paired MB-FFP versus FFP, but no effect on clot formation rate and a surprising 20% increase in clot firmness by ROTEM [86].…”

Section: Overview: Assessing the Quality Of Transfusable Plasmamentioning

confidence: 64%

Quality Assessment of Established and Emerging Blood Components for Transfusion

Acker

Marks

Sheffield

2016

Journal of Blood Transfusion

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Blood is donated either as whole blood, with subsequent component processing, or through the use of apheresis devices that extract one or more components and return the rest of the donation to the donor. Blood component therapy supplanted whole blood transfusion in industrialized countries in the middle of the twentieth century and remains the standard of care for the majority of patients receiving a transfusion. Traditionally, blood has been processed into three main blood products: red blood cell concentrates; platelet concentrates; and transfusable plasma. Ensuring that these products are of high quality and that they deliver their intended benefits to patients throughout their shelf-life is a complex task. Further complexity has been added with the development of products stored under nonstandard conditions or subjected to additional manufacturing steps (e.g., cryopreserved platelets, irradiated red cells, and lyophilized plasma). Here we review established and emerging methodologies for assessing blood product quality and address controversies and uncertainties in this thriving and active field of investigation.

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Section: Overview: Assessing the Quality Of Transfusable Plasmamentioning

confidence: 64%

Quality Assessment of Established and Emerging Blood Components for Transfusion

Acker

Marks

Sheffield

2016

Journal of Blood Transfusion

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“…Treatment with methylene‐blue caused a larger change to increased clot strength, compared to amotosalen‐treated or untreated plasma. Corresponding cryoprecipitate showed, although not significant for all variables, consistent decreasing clot forming potential in the order FFP, FFP(amotosalen) and FFP(methylene‐blue), expressed by longer initiation times, slower propagation rates and weaker clots . Thus, thromboelastographic assays were also helpful to quantify the impact of pathogen inactivation treatment of plasma on its overall haemostatic potential.…”

Section: Whole Blood Donations and Blood Componentsmentioning

confidence: 97%

Thromboelastography as a tool to evaluate blood of healthy volunteers and blood component quality: a review

2019

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Thromboelastography is a technique to evaluate the overall coagulation behaviour of blood and blood components. First, we evaluated the literature concerning the use of thromboelastography for characterizing coagulation behaviour of healthy volunteers, such as blood donors. Overall coagulation is sensitive to gender, most likely caused by the difference in haematocrit and plasma content of male versus female blood. Smaller and less pronounced effects in thromboelastographic response are caused by differences in fibrinogen level or by use of oral contraceptives. Short‐term hypercoagulable effects are observed after smoking or blood donation, while small effects of non‐steroidal anti‐inflammatory drugs on platelets are also present. Second, in whole blood donations, the thromboelastographic variables are also sensitive to storage time and temperature, but are less sensitive to levels of clotting factors. Platelet count and quality have little influence on thromboelastographic variables, and differences are mainly observed at counts <100x109/l, after extended storage time of platelet concentrates or storage under specific conditions, including freezing. Thromboelastographic profiles of plasma samples are mainly affected by residual cell counts, microparticles and fibrinogen levels, and less by levels of clotting factors. Taken together, publications have shown that as an overall clotting test, thromboelastography may support optimization of blood component preparation and storage with regard to temperature, time and secondary and tertiary treatments. Minimal deviations of in vitro quality are most reliable demonstrated when an appropriate assay is chosen.

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“…The intrinsic effects of pathogen inactivation on fibrinogen structure or function are poorly understood. Backholer and colleagues published one of the first studies directly comparing the cryoprecipitate made from amotosalen‐treated plasma and cryoprecipitate made from methylene blue–treated plasma to cryoprecipitate made from untreated plasma. All cryoprecipitate in the Backholer study was made from pools of six ABO‐matched plasma units.…”

Section: Discussionmentioning

confidence: 99%

“…There is a need for an improved cryoprecipitate product with decreased risk of transfusion‐transmitted infections, rapid availability, and an extended shelf life to decrease product wastage. Numerous pathogen reduction processes, including solvent/detergent pathogen reduction technology, methylene blue plus visible light reduction technology, and amotosalen or riboflavin plus ultraviolet light technologies , have been applied to cryoprecipitate. In the past, some pathogen reduction steps in manufacturing cryoprecipitate have been reported to have a negative impact on coagulation factor activity …”

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confidence: 99%

Efficacy of a new pathogen‐reduced cryoprecipitate stored 5 days after thawing to correct dilutional coagulopathy in vitro

et al. 2019

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BACKGROUND Fibrinogen supplementation during bleeding restores clot strength and hemostasis. Cryoprecipitate, a concentrated source of fibrinogen, has prolonged preparation time for thawing, a short shelf life resulting in frequent wastage, and infectious disease risk. This in vitro study investigated the efficacy of a new pathogen‐reduced cryoprecipitate thawed and stored at room temperature for 5 days (PR Cryo) to treat dilutional hypofibrinogenemia, compared to immediately thawed standard cryoprecipitate (Cryo) or fibrinogen concentrate (FC). STUDY DESIGN AND METHODS Ten phlebotomy specimens from healthy volunteers were diluted 1:1 with crystalloid and supplemented with PR Cryo and Cryo (at a dose replicating transfusion of two pooled doses [10 units]) and FC at a dose replicating 50 mg/kg. Changes in clot firmness (thromboelastometry) and in coagulation factor activity were assessed at baseline, after dilution, and after supplementation. RESULTS Clinical dosing was used, as described above, and consequently the FC dose contained 24% and 36% more fibrinogen versus PR Cryo and Cryo, respectively. At baseline, subjects had a median FIBTEM maximum clot firmness of 13.5 mm, versus 6.5 mm after 50% dilution (p = 0.005). After supplementation with PR Cryo, a median FIBTEM maximum clot firmness of 13 mm was observed versus 9.0 mm for Cryo (p = 0.005) or 16.5 mm for FC (p = 0.005). Median factor XIII was higher after PR Cryo (64.8%) versus Cryo (48.3%) (p = 0.005). Fibrinogen activity was higher after FC (269.0 mg/dL) versus PR Cryo (187.0 mg/dL; p = 0.005) or Cryo (193.5 mg/dL; p = 0.005); the difference between PR Cryo and Cryo supplementation (p = 0.445) was not significant. CONCLUSION PR Cryo used 5 days after thawing effectively restores clot strength after in vitro dilution.

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Paired comparison of methylene blue‐ and amotosalen‐treated plasma and cryoprecipitate

Abstract: MB-cryo contained a significantly higher content of FVIII and lower content of FXIII when compared to AS-cryo, with no difference in fibrinogen activity.

Cited by 16 publications

References 20 publications

Quality Assessment of Established and Emerging Blood Components for Transfusion

Quality Assessment of Established and Emerging Blood Components for Transfusion

Thromboelastography as a tool to evaluate blood of healthy volunteers and blood component quality: a review

Efficacy of a new pathogen‐reduced cryoprecipitate stored 5 days after thawing to correct dilutional coagulopathy in vitro

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