<i>In vitro</i> quality of amotosalen‐<scp>UVA</scp> pathogen‐inactivated mini‐pool plasma prepared from whole blood stored overnight

Ravanat, Catherine; Dupuis, Arnaud; Marpaux, Nadine; Naegelen, Christian; Mourey, Guillaume; Isola, Hervé; Laforet, M.; Morel, Pascal; Gachet, Christian

doi:10.1111/vox.12697

Cited by 7 publications

(8 citation statements)

References 42 publications

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“…A total reduction of variability of 55% (volume and coagulation factor concentration) between the units respectively was observed when the plasma units were produced by the novel approach of pooling five donor plasma units to gain six therapeutic plasma units in combination with AS pathogen inactivation. Moderate, but significant losses of coagulation factors (except for vWF) were observed post thawing of PTPs compared to fresh SDPs, findings which are in line with previously published data using amotosalen/UVA PI 12,19,20 and in compliance with European standards 21 . Also, a moderate prolongation of the coagulation time was observed, which is considered likely not being clinically relevant.…”

Section: Discussionsupporting

confidence: 91%

“…Amotosalen/UVA (AS) pathogen inactivation technology (INTERCEPT™ Blood System, Cerus Corporation), a targeted photochemical reaction irreversibly crosslinking nucleic acids, 11 allows the treatment of pools of five plasma units and splitting into six standardised therapeutic units 12 . The key objectives for this production method are the prevention of transmission of infectious agents and the preservation of the haemostatic capacity as well as the clinical effectiveness.…”

Section: Introductionmentioning

confidence: 99%

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Plasma pooling in combination with amotosalen/UVA pathogen inactivation to increase standardisation and safety of therapeutic plasma units

Bubiński¹,

Gronowska²,

Szykuła³

et al. 2021

Transfusion Medicine

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Objectives Assessment of the impact of pooling five single‐donor plasma (SDP) units to obtain six pathogen‐reduced therapeutic plasma (PTP) units on standardisation and the retention of labile coagulation factors. Background SDP shows a high inter‐donor variability with potential implications for the clinical treatment outcome. Additionally, there is still an existing risk for window‐period transmissions of blood borne pathogens including newly emerging pathogens. Methods/Materials Five ABO‐identical SDP units were pooled, treated with the INTERTCEPT™ Blood System (Cerus Corporation, U.S.A.) and split into six PTP units which were frozen and thawed after 30 days. The variability in volume, labile coagulation factor retention and activity was assessed. Results The variability of volumes between the PTP units was reduced by 46% compared to SDP units. The variability in coagulation factor content between the PTP units was reduced by 63% compared to SDP units. Moderate, but significant losses of coagulation factors (except for vWF) were observed in PTPs compared to SDPs. Conclusion The pooling of five SDP units to obtain six PTP units significantly increases product standardisation with potential implications for safety, economics as well as transfusion‐transmitted pathogen safety, making it an interesting alternative to quarantine SDP (qSDP) and pathogen‐reduced SDP.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Plasma pooling in combination with amotosalen/UVA pathogen inactivation to increase standardisation and safety of therapeutic plasma units

Bubiński¹,

Gronowska²,

Szykuła³

et al. 2021

Transfusion Medicine

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“…Studies show no significant decrease in proteins such as antithrombin and protein S that are integral to the clotting cascade. 91 It has been shown that for patients with congenital coagulation factor deficiencies, replacement of coagulation factors in INTERCEPT® plasma exhibited kinetics and therapeutic efficacy similar to conventional FFP. 92 Additionally, liver transplant and therapeutic plasma exchange studies have shown success for the INTERCEPT® system.…”

Section: Intercept® Plasmamentioning

confidence: 99%

“…92 Additionally, liver transplant and therapeutic plasma exchange studies have shown success for the INTERCEPT® system. 91,93…”

Section: Intercept® Plasmamentioning

confidence: 99%

Contemporary resuscitation of hemorrhagic shock: What will the future hold?

Chipman

Jenne

et al. 2020

The American Journal of Surgery

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Resuscitation of the critically ill patient with fluid and blood products is one of the most widespread interventions in medicine. This is especially relevant for trauma patients, as hemorrhagic shock remains the most common cause of preventable death after injury. Consequently, the study of the ideal resuscitative product for patients in shock has become an area of great scientific interest and investigation. Recently, the pendulum has swung towards increased utilization of blood products for resuscitation. However, pathogens, immune reactions and the limited availability of this resource remain a challenge for clinicians. Technologic advances in pathogen reduction and innovations in blood product processing will allow us to increase the safety profile and efficacy of blood products, ultimately to the benefit of patients. The purpose of this article is to review the current state of blood product based resuscitative strategies as well as technologic advancements that may lead to safer resuscitation.

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“…The most studied plasma categories used in iTTP series are: (i) Solvent-Detergent-(SD) FFP, produced by industrial pooling of plasma sources from pools of 100 to 1.500 individual plasma collections or more, depending on the manufacturer, with pathogen inactivation by solvent and detergent treatment; and (ii) Quarantine-(Q) FFP, that has not been modified apart from freezing, thawing and retesting for a limited number of pathogens [19,24]. More recently, new forms of FPP have been made available, including individual or mini-pools of therapeutic plasma pathogen inactivated by Amotosalen-UVA [25]. Uses of different plasma categories in France has varied over time as recentmly discussed in [26].…”

Section: Introductionmentioning

confidence: 99%

Amotosalen-inactivated fresh frozen plasma is comparable to solvent-detergent inactivated plasma to treat thrombotic thrombocytopenic purpura

Garraud

Malot

Herbrecht

et al. 2019

Transfusion and Apheresis Science

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Background: Therapeutic Plasma Exchange (TPE) is the primary therapy of immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP). Efficacy and safety data for TPE of iTTP have been assessed with Quarantine and Solvent-Detergent inactivated (SD) plasma. Here, amotosalen-UVA pathogen inactivated (AI) plasma, also in routine use, was evaluated in iTTP. Methods: We conducted a retrospective review of iTTP cases prospectively reported to the French national registry (2010)(2011)(2012)(2013). Cases reviewed underwent TPE with ≥70% of either AI or SD plasma. The primary endpoint was time to platelet count recovery; secondary endpoints were related to follow-up (sustained remission, relapses, flare-ups and refractoriness). Results: 30 Test patients were identified in the AI group which could be timely matched to 40 Control patients in the SD group. The groups were fairly comparable for clinical presentation. Major findings were: (i) iTTP patients were exposed to lower plasma volumes in the AI group than in the SD group; (ii) Recovery rates were comparable between the groups. Median time to platelet count recovery (> 150 × 10 9 /L) trended to be shorter in the AI group though non significantly. Tolerance of AI vs SD plasma was of comparable frequency and severity in either group. Conclusion: TPE with Amotosalen-inactivated plasma demonstrated therapeutic efficacy and tolerability for iTTP patients. In view of the retrospective design, confirmation of these results is required in larger prospective studies.

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In vitro quality of amotosalen‐UVA pathogen‐inactivated mini‐pool plasma prepared from whole blood stored overnight

Abstract: Frozen WB-derived AUVA-plasma prepared from mini-pools within 19 h of WB-collection met the quality standards required for TP and retained hemostatic capacity for up to 12 months. This product could provide a cost-effective convenient substitute for apheresis plasma.

Cited by 7 publications

References 42 publications

Plasma pooling in combination with amotosalen/UVA pathogen inactivation to increase standardisation and safety of therapeutic plasma units

Plasma pooling in combination with amotosalen/UVA pathogen inactivation to increase standardisation and safety of therapeutic plasma units

Contemporary resuscitation of hemorrhagic shock: What will the future hold?

Amotosalen-inactivated fresh frozen plasma is comparable to solvent-detergent inactivated plasma to treat thrombotic thrombocytopenic purpura

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