UnknownPhase 1/2

Reversal of Dual Antiplatelet Therapy With Cold Stored Platelets

United States60 participantsStarted 2018-12-03

Plain-language summary

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.

Who can participate

Age range18 Years – 59 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject self-reports that he or she feels well and healthy
✓. Subjects must be 18-59 years old, of either sex
✓. Temperature: less than or equal to 99.5 F
✓. Resting blood pressure: systolic less than or equal to 180 mmHg, diastolic less than or equal to100 mmHg
✓. Resting heart rate: 40 to 100 beats per minute
✓. Weight: greater than or equal to110 pounds,
✓. Hematocrit: greater than or equal to 35 percent for females, greater than or equal to 38 percent for males, but not greater than 55 percent
✓. Platelet count able to achieve target platelet yield per apheresis machine configuration parameters

Exclusion criteria

✕. Active acute infection or suspected active infection, temperature above 100 F or taking antibiotic
✕

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: Measured at baseline, pre-transfusion (after administration of dual anti-platelet therapy), 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion

Trial details

NCT IDNCT03787927

SponsorBloodworks

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-03

View on ClinicalTrials.gov More Bleeding trials

Plain-language summary

Who can participate

Age range18 Years – 59 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject self-reports that he or she feels well and healthy
✓. Subjects must be 18-59 years old, of either sex
✓. Temperature: less than or equal to 99.5 F
✓. Resting blood pressure: systolic less than or equal to 180 mmHg, diastolic less than or equal to100 mmHg
✓. Resting heart rate: 40 to 100 beats per minute
✓. Weight: greater than or equal to110 pounds,
✓. Hematocrit: greater than or equal to 35 percent for females, greater than or equal to 38 percent for males, but not greater than 55 percent
✓. Platelet count able to achieve target platelet yield per apheresis machine configuration parameters

Exclusion criteria

✕. Active acute infection or suspected active infection, temperature above 100 F or taking antibiotic
✕

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: Measured at baseline, pre-transfusion (after administration of dual anti-platelet therapy), 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion