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 range

18 Years – 59 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 59 Years

Sex

ALL

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

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

Reversal of Dual Antiplatelet Therapy With Cold Stored Platelets

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Reversal of Dual Antiplatelet Therapy With Cold Stored Platelets

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria