This study aims to determine whether cold-stored platelets (CSP) are equally, more effective, or uniquely effective at reversing the effect of dual antiplatelet therapy in healthy human subjects compared to room-temperature-stored platelets (RTP). The investigators plan to enroll healthy human subjects without risk factors for bleeding to achieve 60 complete data sets. Each subject will donate two apheresis platelet units. One platelet unit will be stored in the cold (CSP) and one platelet unit will be stored at room temperature (RTP). Subjects will be given dual anti-platelet therapy (aspirin and clopidogrel) prior to autologous transfusion of each unit. Platelet function testing will be performed before and after transfusion to measure reversal of the antiplatelet drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The participant will receive an autologous platelet transfusion of their room-temperature-stored platelets after 5 days of storage.
The participant will receive an autologous platelet transfusion of their cold-stored platelets after 5 days of storage.
The participant will receive an autologous platelet transfusion of their cold-stored platelets after 10 days of storage.
The participant will receive an autologous platelet transfusion of their cold-stored platelets after 15 days of storage.
Aspirin (325mg) will be administered the day before every transfusion.
Clopidogrel (600mg) will be administered the day before every transfusion.
Bloodworks Northwest Research Institute
Seattle, Washington, United States
Verify Now (PRU): αIIbβ3 (GPIIb-IIIa) integrin activation changes between DAPT loaded pre-transfusion, 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion, baseline
Measured by Verify Now (PRU)
Time frame: Measured at baseline, pre-transfusion (after administration of dual anti-platelet therapy), 1 hour post-transfusion, 24 hour post-transfusion
Verify Now: αIIbβ3 (GPIIb-IIIa) integrin activation changes between DAPT loaded pre-transfusion, 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion, baseline
Measured by Verify Now (ARU)
Time frame: Measured at baseline, pre-transfusion (after administration of dual anti-platelet therapy), 1 hour post-transfusion, 24 hour post-transfusion
PAC-1: αIIbβ3 (GPIIb-IIIa) integrin activation changes between DAPT loaded pre-transfusion, 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion, baseline
Measured by PAC-1 antibody binding by flow cytometry
Time frame: Measured at baseline, pre-transfusion (after administration of dual anti-platelet therapy), 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion
LTA: αIIbβ3 (GPIIb-IIIa) integrin activation changes from DAPT loaded pre-transfusion, 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion, baseline
Light Transmittance Aggregometry
Time frame: Measured at baseline, pre-transfusion (after administration of dual anti-platelet therapy), 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion
P-Selectin:αIIbβ3 (GPIIb-IIIa) integrin activation changes between DAPT loaded pre-transfusion, 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion, baseline
Measured by alpha-granule secretion (P-Selectin) by flow cytometry
Time frame: Measured at baseline, pre-transfusion (after administration of dual anti-platelet therapy), 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion
Beeding time testing (in-vivo) changes between DAPT loaded pre-transfusion, 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion, baseline
in-vivo subject testing
Time frame: Measured at baseline, pre-transfusion (after administration of dual anti-platelet therapy), 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion
CBC changes between DAPT loaded pre-transfusion, 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion, baseline
Time frame: Measured at baseline, pre-transfusion (after administration of dual anti-platelet therapy), 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion
Platelet unit blood gas: changes during storage
during storage of the units
Time frame: day of collection, day of transfusion
Platelet unit Annexin V: changes during storage
Time frame: day of collection, day of transfusion
Thromboxane B2 ELISA changes between DAPT loaded pre-transfusion, 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion, baseline
Time frame: Measured at baseline, pre-transfusion (after administration of dual anti-platelet therapy), 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion
Vasodilator-stimulated phosphoprotein (VASP) changes
Time frame: Measured at baseline, pre-transfusion (after administration of dual anti-platelet therapy), 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion
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