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Seven-Day Platelets: Quality Implications, Safety Benefits, and Implementation Challenges

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Seven-Day Platelets: Quality Implications, Safety Benefits, and Implementation Challenges Seven-Day Platelets: Quality Implications, Safety Benefits, and Implementation Challenges 10/13/2018 Faculty Disclosures The following faculty have no relevant financial relationships to disclose: – Peter Schubert – Dirk de Korte www.aabb.org 2 Faculty Disclosures The following faculty have a relevant financial relationship: – Sandra Ramirez-Arcos MSc, PhD : – Michael Jacobs bioMerieux: Invited guest speaker by bioMerieux Verax: Consultant ASPAC Industrial Microbiology to the Japanese Pall: Grant/Research Support Red Cross Symposium Gambro: Grant/Research Support Cerus: Invited Speaker to a Cerus-sponsored Meeting Hemosystem: Grant/Research Support Immunetics: Consultant – Ralph Vassallo MD GenPrime: Grant/Research Support Grant/Research Support bioMerieux: Consultant Fenwal: Grant/Research Support Fresenius Kabi: Consultant Charles Rivers Labs: Grant/Research Support HemaNext: Consultant bioMerieux: Consultant Cerus Corp: Consultant BioSense Technologies: Consultant Terumo BCT: Speaker's Bureau Lynntech: Blood Systems: Consultant www.aabb.org 3 Learning Objectives • Compare in vitro quality of 5-day and 7-day platelets • Review clinical outcomes of transfusing 5-day and 7-day platelets • Discuss the impact of extending platelet shelf-life to 7 days on patient safety • Analyze the challenges posed to blood suppliers and blood centers with the extension of platelet shelf-life to 7 days www.aabb.org 4 In vitro quality data to support 7-day platelets AABB Educational Session, Boston, October 13, 2018 Dr. Peter Schubert • Research Associate, Centre for Innovation, Canadian Blood Services • Clinical Associate Professor, Pathology, University of British Columbia Our laboratory received research funding from TerumoBCT, MacoPharma and HemaNext. 6 Topics to be covered • Aspects of the platelet shelf-life • Learn about platelet function/assays to determine in vitro and in vivo platelet quality • Compare in vitro and in vivo quality of platelets stored for 5 vs. 7 days 7 Shelf-life of platelet concentrates 1986: FDA reduces storage time from 7 days -> 5 days • Risk of bacterial contamination Platelet Platelet In vitro/in vivo quality deterioration • Introduction of pathogens by Safety Quality (platelet storage lesion) donor → This short shelf life presents a significant challenge in meeting the platelet needs of hospital patients, especially around long weekends. → It also led to discards due to outdates. 8 Tools to assess in vitro quality Quality monitoring program (QMP) MPV Quality Control Research in vitro pH parameters pH Glucose Platelet yield Lactate Platelet response (to agonist) (determined by platelet count pO2 Platelet microvesicles and PC volume) pCO2 Annexin-V (apoptosis) rWBC Platelet activation (P-selectin) Platelet aggregation Morphology (score) Omics technologies … Levin et al, Transfusion, 2012 9 In vivo quality: recovery and survival Slichter et al, Blood, 2013 r2 ranging from 0.08 to 0.31 recovery survival Platelet count 0 3 6 12 24 Annexin-V (%) ESC (%) HSR (%) Post-transfusion (hrs) In) Cr) PLT recovery (%) PLT 51 111 pCO2 (mmHg) pO2 (mmHg) Glucose (mM) pH Stored PC ( Fresh PLTs ( PLTs Fresh • Poor correction between in vitro parameters and PLT recovery • Same results seen for PLT survival (r2 ranging from 0.03 to 0.41) Studies assessing 7-day platelet quality Only a few studies investigating the quality comparing 5-day with 7-day platelets Some studies assessed quality after extended storage Studies variables Storage solution Storage Production method (PRP, pooled, apheresis …) 11 Studies example I Sandgren & Saeed, Blood Transfusion, 2011 Pooled PCs in 70% SSP+ Storage time *P<0.05 Day 5 Day 7 Parameter **P<0.01 PLT # [109/L] 886 ± 96 833 ± 106 n.s. pH (37°C) 7.12 ± 0.02 7.14 ± 0.03 n.s. Glucose [mM] 4.9 ± 0.4 3.9 ± 0.5 n.s. Lactate [mM] 8.8 ± 0.4 10.6 ± 0.7 n.s. CD62P [%] 22.5 ± 3.8 25.4 ± 3.0 * Pac-1 [%] 23.0 ± 7.1 15.3 ± 3.6 n.s. ESC [%] 14.4 ± 4.2 10.5 ± 2.5 ** 12 Studies example II Dumont & VandenBroeke, Transfusion, 2003 Aphesesis PC in plasma PLT # *P<0.05 Day 5 Day 7 group **P<0.01 1 7.58 ± 0.09 7.39 ± 0.12 * 2 7.46 ± 0.04 7.24 ± 0.06 * pH (37°C) 3 6.98 ± 0.62 6.76 ± 0.74 n.s. 4 7.29 ± 0.17 7.21 ± 0.18 n.s. 1 26.9 ± 5.7 44.1 ± 5.9 * 2 25.4 ± 8.0 39.8 ± 4.5 n.s. CD62P [%] 3 25.9 ± 26.9 49.4 ± 39.6 n.s. 4 15.3 ± 8.5 21.5 ± 8.4 n.s. PLT # [109/L]: 1: 1.1 – 1.8; 2: 2.4 – 2.8 ; 3: 3.5 – 4.5 ; 4: 5.1 – 5.9 13 n=24 Day 5 Day 7 Study example III Recovery (%) 63.0 ± 11.2 53.9 ± 13.8 p > 0.05 Dumont et al., Transfusion, 2002 Survival (hours) 160.8 ± 37.5 133.6 ± 45.1 Studies example IV Slichter et al., Blood, 2013 There were some significant differences in vivo recovery and no differnces in survival between stored platelets at 5- and 7-days of storage. 14 CBS data to support the move from 5- to 7-day platelets Pooled buffy coat PCs n=26 Brief data interpretation: Day 5 Day 7 p-value Most parameters exhibit a 9 821 ± 79 825 ± 109 0.743 PLT count (x 10 /L) statistically significant difference pH 7.24 ± 0.07 7.19 ± 0.08 0.011 between day 5 and day 7 (trend Glucose (mM) 14.6 ± 1.4 13.4 ± 1.3 4 x 10-11 into the same direction). -4 Lactate (mM) 12.2 ± 0.8 15.7 ± 1.3 9 x 10 Within the standard deviations, CD62P (%) 33.4 ± 3.6 38.0 ± 4.2 2 x 10-9 the results for these parameters are quite similar. Apheresis PCs n=21 Day 5 Day 7 p-value Data show a continuation of the development of platelet storage PLT count (x 109/L) 1164 ± 80 1208 ± 111 0.123 lesion. pH 7.20 ± 0.1 7.10 ± 0.1 5 x 10-6 pH values are still in spec (>>6.4) Glucose (mM) 13.3 ± 1.6 10.7 ± 1.8 3 x 10-9 Lactate (mM) 10.5 ± 2.8 14.5 ± 3.9 1 x 10-7 Platelet activation increases as a result of degranulation. CD62P (%) 31.1 ± 8.0 40.3 ± 11.3 6 x 10-5 15 Introduction of 7-day platelets: a quick turn-around in Canada 16 Introduction of 7-day platelets: a quick turn-around in Canada Delaying sampling for bacterial detection from 24 hours to 36 hours or longer, along with increased sampling volume that allows for testing growth in both aerobic and anaerobic conditions, improves the safety of platelet concentrates (Sandra Ramirez- Arcos) For most variables, the difference between 5- and 7- days of storage was smaller than the observed standard deviation (Dana Devine) Platelet products continue to fulfill all quality control requirements Modeling the potential impact of a seven-day shelf life on inventory revealed improved product availability and an about a 30 per cent reduction in product wastage (John Blake) 17 Pathogen inactivation technologies: an extra layer of safety Safety Shelf life Quality UV light ± photosensitizer • Risk of bacterial contamination • Introduction of pathogens by Pathogen • Numerous in vitro studies report reduced that PITs have some negative donor PC effects on the quality of platelet concentrates • Clinical studies show evidence of PIT to cover low level of pathogens (not minor decreases of platelet in detected by BacT systems) PIT vivo survival, but these have not Pathogens not screened for (no test been associated with increased available) 5-day 7-day storage bleeding in patients receiving Unknown emerging pathogens (Zika et al.) pathogen-reduced platelets 18 Conclusion In vitro data show higher PSL development on day 7 vs. day 5, but pH still in spec In vivo (radio-labeled) data support the 5-day to 7-day shelf-life change → Improved inventory management → Reduction of wastage → Cost reduction 19 Visit blood.ca Seven-Day Platelets A Patient Safety Perspective Ralph R. Vassallo, MD, FACP Vitalant EVP / Chief Medical & Scientific Officer Adjunct Associate Professor of Medicine, University of Pennsylvania School of Medicine October 14, 2018 The 7-Day RT-Stored Platelet • 1983-1986 & 2005-2008 under PASSPORT in the US • Currently available in Europe • Convenient collection days, reduces outdates • 2006 UNC data: 6 mo. pre/post study with 60% in-house 7d unit collections → 54% ↓ in outdates with modal shift from D3 to D4 • 2017 Héma-Québec data: 63% ↓ with modal shift from D4 to D6 • The price for those 2 additional days: • Lower CCIs, perhaps increased unit use (particularly with additional ‘quality hits’ such as PAS and PRT) • Equivalent 7d bleeding outcomes in prophylaxis… other patients? Hay SN. J Clin Apher 2007;22:283; Delage G. Transfusion 2016;56(S4):28A - 22 data from oral abstract and personal communication. July 18th BPAC Please comment on the advantages and disadvantages of each of the various strategies to control the risk of bacterial contamination in platelets, including the scientific evidence and the operational considerations involved 5-day dating options: • 8-10 mL 1° culture with Days 4 & 5 Point-of-Care testing • 8-10 mL 1° culture with 5 mL Day 3 BacT (Hopkins) • Minimal Proportional Sample Volume [MPSV] ≥ 3.8% 1° culture (BSI) • Pathogen Reduction Technology (7d in Europe) 7-day dating options: • 1° culture with Days 4, 5, 6 & 7 Point-of-Care testing • 16 mL 1° culture with 16 mL Day 4 BacT (IBTS; BacT is US FDA-approved) • 16 mL per split 1° culture (NHSBT; Delayed Lg. Vol. Culture [DLVC]) 23 Cerus INTERCEPT Blood System Step 1 Step 2 Step 3 Process Complete Amotosalen Illumination CAD Storage Mirasol PRT System 24 French, Swiss & Belgian HV Experience: 7d PRT Plts Benjamin RJ.
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