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Abstract

Blood Center/Blood Hospital-Based Donor Center

Oral Abstract - SPOTLIGHT Extended Blood Storage

OA3-AM24-SN-23 - Novel Anticoagulant/Additive Solution Maintains the Hemostatic Function of Cold Stored Whole Blood for 56 Days

Sunday, October 20, 2024
3:30 PM - 5:00 PM  
Location: 362
CE: Zero

    Presenting Author(s)

  • Jose Cancelas, MD, PhD (he/him/his)

    Executive Director, Connell and O'Reilly Families Cell Manipulation Core Facility
    Dana-Farber Cancer Institute, Harvard Medical School
    Boston, Massachusetts, United States

    Disclosure(s): Fresenius Kabi: Consultant/Advisory Board (Ongoing); Hemanext: Consultant/Advisory Board (Terminated, June 2, 2024); Hemerus LLC: Consultant/Advisory Board (Ongoing), Grant/Research Support (Ongoing); PLATEFUSE: Patent holder (Ongoing); PRESERVATION BIO: Consultant/Advisory Board (Ongoing), Grant/Research Support (Ongoing); Rion: Consultant/Advisory Board (Ongoing); Teleflex: Consultant/Advisory Board (Ongoing); Terumo BCT: Grant/Research Support (Terminated, June 2, 2024); Velico Medical: Consultant/Advisory Board (Ongoing), Grant/Research Support (Ongoing)

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Disclosure(s):
Jose Cancelas, MD, PhD: Fresenius Kabi: Consultant/Advisory Board (Ongoing); Hemanext: Consultant/Advisory Board (Terminated, June 2, 2024); Hemerus LLC: Consultant/Advisory Board (Ongoing), Grant/Research Support (Ongoing); PLATEFUSE: Patent holder (Ongoing); PRESERVATION BIO: Consultant/Advisory Board (Ongoing), Grant/Research Support (Ongoing); Rion: Consultant/Advisory Board (Ongoing); Teleflex: Consultant/Advisory Board (Ongoing); Terumo BCT: Grant/Research Support (Terminated, June 2, 2024); Velico Medical: Consultant/Advisory Board (Ongoing), Grant/Research Support (Ongoing)
Background/Case Studies: Transfusion of whole blood (WB) is a life-saving procedure in massive bleeding therapy. Storage of WB in citrate phosphate dextrose adenine solution (CPDA-1) is limited to a shelf life of 35 days. This pilot study assessed and characterized the viability and clotting activity of cellular and plasma components of WB stored in APEX™ (Hemerus), a novel anticoagulant/additive solution system for WB, for up to 56 days.

Study

Design/Methods: Under an approved protocol, 500 mL (±10%) of WB from healthy donors was collected in 70 mL of CPDA-1, leukoreduced with a platelet sparing filter (Terumo BCT), pooled into ABO compatible two-unit pools, and split into matched pairs of equal volume designated as Test or Control units. Test units received an additional 50±1 mL of APEX™ solution. A total of 15 paired WB units were evaluated at Day 0 (D0) and periodically up to Day 56 (D56) of storage at 1-6°C across two centers. Quality testing on WB included cell counts, ATP concentrations, hemolysis level, blood gases and metabolites, coagulation factor levels, thromboelastography (TEG), thrombin generation, platelet aggregometry, and bacterial culture.

Results/Findings: Compared to Control at D56 of storage, APEX units displayed higher ATP concentration (3.14 vs 2.18 μmol/gHb), ATP as % of Day 0 (64 vs 44 %, both p< 0.001), pH (6.53 vs 6.50, p=0.01), and HCO3- (8.0 vs 5.4 mM, p< 0.001). D56 stored APEX units had greater platelet contribution to TEG clot strength (Figure A) and reduced time for tissue factor dependent thrombin generation. Multi-agonist induced platelet aggregation was similar between groups. Proportional dilutional effects were observed in relative levels of hemoglobin, fibrinogen, factor VIII, factor V and protein S activity in APEX units, remaining within the reference levels by D56. RBC hemolysis of APEX units at D56 averaged 0.5%. No bacterial contamination was detected at the end of storage.

Conclusions: This pilot study showed efficacy in storing whole blood for 56 days using a novel anticoagulant/additive solution, extending its shelf life by three weeks with retained plasma coagulation and platelet function. Implications include improved efficiency of whole blood therapy, vital for blood availability in remote hospitals and military battlefield resuscitation. Further studies are recommended to support licensure of this novel technology.