Quality of therapeutic plasma—requirements for marketing authorization

Heiden, M.; Seitz, Rainer

doi:10.1016/s0049-3848(02)00152-4

Cited by 21 publications

(17 citation statements)

References 21 publications

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“…α2PI was retained at 80 percent of baseline activity. The factor activities were within the reported reference ranges for conventional plasma and were suitable for transfusion support 16,17 …”

Section: Discussionsupporting

confidence: 53%

Coagulation function in fresh‐frozen plasma prepared with two photochemical treatment methods: methylene blue and amotosalen

et al. 2007

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BACKGROUND:Pathogen inactivation of plasma intended for transfusion is now the standard of care in Belgium. Two methods for treatment of single plasma units are available: amotosalen plus ultraviolet A light and methylene blue plus visible light. This study compared the quality and stability of plasma treated with these two methods. STUDY DESIGN AND METHODS: Plasma units made from a pool of two ABO-matched fresh apheresis units were photochemically treated with either amotosalen (PCT-FFP) or methylene blue (MB-FFP). A total of 12 paired samples were evaluated. Plasma coagulation function was assessed at three time points: immediately after treatment, after 30 days of frozen storage, and an additional 24 hours at 4°C after thawing. Comparison between PCT-FFP and MB-FFP was assessed with the paired t test and a p value of less than 0.05 indicated statistical significance. RESULTS: Based on statistical analysis, mean levels of factor (F)II, FXII, FXIII, von Willebrand antigen, ADAMTS-13, D-dimers, and protein C were equivalent between PCT-FFP and MB-FFP for all three time points. PCT-FFP exhibited shorter mean prothrombin time, activated partial thromboplastin time (two time points), and thrombin time and higher mean levels of fibrinogen, FXI, and protein S than MB-FFP. Retention of FV, FVII, FVIII, FX, or von Willebrand factor:ristocetin cofactor in PCT-FFP was either equivalent to or higher than MB-FFP. MB-FFP contained higher mean levels of plasminogen, antithrombin, and plasmin inhibitor than PCT-FFP. Retention of F IX in MB-FFP was higher than PCT-FFP only after the 4°C storage after thawing. CONCLUSION: There is adequate preservation of therapeutic coagulation factor activities in both PCT-FFP and MB-FFP. The overall coagulation factor levels and stability of PCT-FFP were better preserved than MB-FFP.

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Section: Discussionsupporting

confidence: 53%

Coagulation function in fresh‐frozen plasma prepared with two photochemical treatment methods: methylene blue and amotosalen

et al. 2007

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“…This compares favorably with the standard 25% to 40% reduction caused by freezing and thawing FFP. 14,15 Industry standards for assessing the quality of FFP require the thawed FFP to maintain factor V, factor VIII, and antithrombin III levels of at least 70%. 14,15 Our study demonstrated that the LP retained much greater than the required 70%.…”

Section: Commentmentioning

confidence: 99%

Lyophilized Plasma for Resuscitation in a Swine Model of Severe Injury

et al. 2009

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“…One might hypothesize that this is due to the freezing process, which ruptures the cell walls in the remaining WBC, as leukoreduction leaves < 1×10 6 WBC/unit. Other studies also have described the different effects of filtration of interleukins, histamine, and TNF in filtrated blood components [18]. However, clinically relevant concentrations of these substances have never been determined [19].…”

Section: What Are the Clinical Effects Of Plasma?mentioning

confidence: 99%

Plasma in the PICU: why and when should we transfuse?

2013

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Whereas red blood cell transfusions have been used since the 19th century, plasma has only been available since 1941. It was originally mainly used as volume replacement, mostly during World War II and the Korean War. Over the years, its indication has shifted to correct coagulation factors deficiencies or to prevent bleeding. Currently, it remains a frequent treatment in the intensive care unit, both for critically ill adults and children. However, observational studies have shown that plasma transfusion fail to correct mildly abnormal coagulation tests. Furthermore, recent epidemiological studies have shown that plasma transfusions are associated with an increased morbidity and mortality in critically ill patients. Therefore, plasma, as any other treatment, has to be used when the benefits outweigh the risks. Based on observational data, most experts suggest limiting its use either to massively bleeding patients or bleeding patients who have documented abnormal coagulation tests, and refraining for transfusing plasma to nonbleeding patients whatever their coagulation tests. In this paper, we will review current evidence on plasma transfusions and discuss its indications.

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Quality of therapeutic plasma—requirements for marketing authorization

Cited by 21 publications

References 21 publications

Coagulation function in fresh‐frozen plasma prepared with two photochemical treatment methods: methylene blue and amotosalen

Coagulation function in fresh‐frozen plasma prepared with two photochemical treatment methods: methylene blue and amotosalen

Lyophilized Plasma for Resuscitation in a Swine Model of Severe Injury

Plasma in the PICU: why and when should we transfuse?

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