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BleedingPhase 1/2R-DAPTNCT03787927

Reversal of Dual Antiplatelet Therapy With Cold Stored Platelets

A Phase 1/2 study testing Autologous Platelet Transfusion (room-temperature-stored), Autologous Platelet Transfusion (cold-stored 5 days) and Autologous Platelet Transfusion (cold-stored 10 days) in people with Bleeding and Platelet Dysfunction Due to Drugs, run by Bloodworks at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
What is being tested?
Autologous Platelet Transfusion (room-temperature-stored), Autologous Platelet Transfusion (cold-stored 5 days) and Autologous Platelet Transfusion (cold-stored 10 days)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
3 Dec 2018to 3 Dec 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject is in good health, is taking no excluded medications and meets platelet donor suitability requirements aimed at assuring donor safety.
  • 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
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  • 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
  • Subjects must be able to read, understand and sign the informed consent document and commit to the study follow-up schedule. The ability to read and speak English is required for participation.
  • Subject must agree to avoid taking any aspirin or aspirin-containing drugs (e.g., Alka-Seltzer, Bufferin, Excedrin) or NSAIDs (e.g.,Feldene, Motrin, Aleve, Advil) or other drugs known to affect platelet function throughout their study participation.
  • Subjects must agree to avoid calcium channel blockers such as amlodipine (Norvasc), felodipine, and verapamil (Verelan, Calan) and proton pump inhibitors (PPIs) such as omeprazole (Prilosec), lansoprazole (Prevacid), esomeprazole (Nexium) and pantoprazole (Protonix) until all study blood draws are concluded. These classes of drugs may interfere with the action of clopidogrel and diminish its antiplatelet effect.
  • Subjects must have "good veins" for apheresis platelet collection and drawing blood samples.
  • Women of child bearing potential must agree to use an effective method of contraception during the course of the study. The following methods of contraception will be considered 'effective' when self-reported by subject; abstinence, intrauterine contraception devices, hormonal methods, barrier methods or history of sterilization.
  • Subject has phone and e-mail for contact and notification, and is able to come to the research site for approximately 9 visits over up to approximately 64 days.

Who cannot join

  • Healthy subjects will be excluded from the study for any of the following reasons:
  • Active acute infection or suspected active infection, temperature above 100 F or taking antibiotic
  • Active immune/inflammatory condition (e.g. gout, systemic lupus erythematosus, allograft rejection)
  • History of heart disease, including endorsement of shortness of breath with mild exertion (at the discretion of the PI).
  • History of significant liver, kidney, GI, blood, endocrine/metabolic, autoimmune or pulmonary disease, untreated hypertension and or metabolic syndrome (at the discretion of the PI).
  • Diabetes Mellitus
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  • Cancer of any kind (exceptions being basal or squamous cell cancers of the skin), under treatment or resolved
  • History of bleeding events, family history of bleeding events, or known genetic disorder with bleeding diathesis
  • A family history of venous or arterial thrombosis before the age of 50 in first degree relatives
  • A personal history of DVT, venous or arterial thrombosis, blood clots or stroke
  • History of having been prescribed clopidogrel (Plavix), ticlopidine (Ticlid) or Ticagrelor (Brilinta).
  • Subject has taken any aspirin or aspirin-containing drugs (e.g., Alka-Seltzer, Bufferin, Excedrin) or NSAIDs (e.g.,Feldene, Motrin, Aleve, Advil) or other drugs known to affect platelet function within 14 days prior to screening.
  • Chronic NSAID therapy
  • Chronic steroid therapy
  • Known allergy to aspirin or clopidogrel
  • Subjects who are taking, or have taken within 14 days any of the following class of drugs protone pump inhibitors (PPIs) such as omeprazole, pantoprazole, lansoprazole, esomeprazole lipid lowering drugs/statins anticoagulants ACE-inhibitors phenytoine tolbutamide calcium channel blockers such as amlodipine, felodipine, verapamil
  • Current drug or alcohol dependence by subject's declaration.
  • Currently pregnant or nursing as assessed during interview. A urine pregnancy test prior to apheresis is required for women of childbearing potential.
  • Subject plans to participate in contact sports during study/observational period such as boxing, rugby, American football, soccer, or other risky recreational hobbies at the discretion of the investigator.
  • Unwilling or unable to comply with the protocol in the opinion of the investigator.
  • Participation in an experimental drug/device study within the past 30 days (other than this study). Subjects who have received an infusion on this study may not be re-enrolled.
  • Average initial (only for the first PFT) aggregation responses to ADP less than or equal to 60% by aggregometry platelet function testing.
  • Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Bloodworks Northwest Research Institute

    Seattle, Washington, 98102

Other trials in United States

About this study

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.

Being tested
Autologous Platelet Transfusion (room-temperature-stored), Autologous Platelet Transfusion (cold-stored 5 days), Autologous Platelet Transfusion (cold-stored 10 days), Autologous Platelet Transfusion (cold-stored 15 days), Aspirin
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Platelet Transfusion (room-temperature-stored)Drug

    The participant will receive an autologous platelet transfusion of their room-temperature-stored platelets after 5 days of storage.

  • Autologous Platelet Transfusion (cold-stored 5 days)Drug

    The participant will receive an autologous platelet transfusion of their cold-stored platelets after 5 days of storage.

  • Autologous Platelet Transfusion (cold-stored 10 days)Drug

    The participant will receive an autologous platelet transfusion of their cold-stored platelets after 10 days of storage.

  • Autologous Platelet Transfusion (cold-stored 15 days)Drug

    The participant will receive an autologous platelet transfusion of their cold-stored platelets after 15 days of storage.

  • AspirinDrug

    Aspirin (325mg) will be administered the day before every transfusion.

  • ClopidogrelDrug

    Clopidogrel (600mg) will be administered the day before every transfusion.

Study groups in NCT03787927
Study groupRoleWhat they receive
5 day CSP, then 5 day RTPOtherParticipants will first complete collection and transfusion of 5 day autologous CSP (cold-stored platelet). Then they will complete collection and transfusion of 5 day autologous RTP (room-temperature-stored platelets). The day before each transfusion, Aspirin (325mg) and Clopidogrel (600mg) will be administered. The first 20 participants who complete the study will be randomized to this arm or '5 day RTP, then 5 day CSP.' Interventions include: Aspirin, Clopidogrel, Autologous Platelet Transfusion (cold-stored 5 days), Autologous Platelet Transfusion (room-temperature-stored 5 days)
Receives: Drug: Autologous Platelet Transfusion (room-temperature-stored); Drug: Autologous Platelet Transfusion (cold-stored 5 days); Drug: Aspirin; Drug: Clopidogrel
5 day RTP, then 5 day CSPOtherParticipants will first complete collection and transfusion of 5 day autologous RTP (room-temperature-stored platelets). Then they will complete collection and transfusion of 5 day autologous CSP (cold-stored platelets). The day before each transfusion, Aspirin (325mg) and Clopidogrel (600mg) will be administered. The first 20 participants who complete the study will be randomized to this arm or '5 day CSP, then 5 day RTP.' Interventions include: Aspirin, Clopidogrel, Autologous Platelet Transfusion (cold-stored 5 days), Autologous Platelet Transfusion (room-temperature-stored 5 days)
Receives: Drug: Autologous Platelet Transfusion (room-temperature-stored); Drug: Autologous Platelet Transfusion (cold-stored 5 days); Drug: Aspirin; Drug: Clopidogrel
5 day RTP, then 10 day CSPOtherParticipants will first complete collection and transfusion of 5 day autologous RTP (room-temperature-stored platelets). Then they will complete collection and transfusion of 10 day autologous CSP (cold-stored platelets).The day before each transfusion, Aspirin (325mg) and Clopidogrel (600mg) will be administered. After the first 20 complete data sets are obtained from subjects, the next 20 complete data sets will be obtained (if progression to this arm is indicated) by randomizing subjects between '5 day RTP, then 10 day CSP' and '10 day CSP, then 5 day RSP.' Interventions include: Aspirin, Clopidogrel, Autologous Platelet Transfusion (cold-stored 10 days), Autologous Platelet Transfusion (room-temperature-stored 5 days)
Receives: Drug: Autologous Platelet Transfusion (room-temperature-stored); Drug: Autologous Platelet Transfusion (cold-stored 10 days); Drug: Aspirin; Drug: Clopidogrel
5 day RTP, then 15 day CSPOtherParticipants will first complete collection and transfusion of 5 day autologous RTP (room-temperature-stored platelets). Then they will complete collection and transfusion of 15 day autologous CSP (cold-stored platelets). The day before each transfusion, Aspirin (325mg) and Clopidogrel (600mg) will be administered. After the first 40 complete data sets are obtained from subjects, the next 20 complete data sets will be obtained (if progression to this arm is indicated) by randomizing subjects between '5 day RTP, then 15 day CSP' and '15 day CSP, then 5 day RSP.' Interventions include: Aspirin, Clopidogrel, Autologous Platelet Transfusion (cold-stored 15 days), Autologous Platelet Transfusion (room-temperature-stored 5 days)
Receives: Drug: Autologous Platelet Transfusion (room-temperature-stored); Drug: Autologous Platelet Transfusion (cold-stored 15 days); Drug: Aspirin; Drug: Clopidogrel
10 day CSP, then 5 day RTPOtherParticipants will first complete collection and transfusion of 10 day autologous CSP (cold-stored platelet). Then they will complete collection and transfusion of 5 day autologous RTP (room-temperature-stored platelets).The day before each transfusion, Aspirin (325mg) and Clopidogrel (600mg) will be administered. After the first 20 complete data sets are obtained from subjects, the next 20 complete data sets will be obtained (if progression to this arm is indicated) by randomizing subjects between '5 day RTP, then 10 day CSP' and '10 day CSP, then 5 day RSP.' Interventions include: Aspirin, Clopidogrel, Autologous Platelet Transfusion (cold-stored 10 days), Autologous Platelet Transfusion (room-temperature-stored 5 days)
Receives: Drug: Autologous Platelet Transfusion (room-temperature-stored); Drug: Autologous Platelet Transfusion (cold-stored 10 days); Drug: Aspirin; Drug: Clopidogrel
15 day CSP, then 5 day RTPOtherParticipants will first complete collection and transfusion of 15 day autologous CSP (cold-stored platelet). Then they will complete collection and transfusion of 5 day autologous RTP (room-temperature-stored platelets). The day before each transfusion, Aspirin (325mg) and Clopidogrel (600mg) will be administered. After the first 40 complete data sets are obtained from subjects, the next 20 complete data sets will be obtained (if progression to this arm is indicated) by randomizing subjects between '5 day RTP, then 15 day CSP' and '15 day CSP, then 5 day RSP.' Interventions include: Aspirin, Clopidogrel, Autologous Platelet Transfusion (cold-stored 15 days), Autologous Platelet Transfusion (room-temperature-stored 5 days)
Receives: Drug: Autologous Platelet Transfusion (room-temperature-stored); Drug: Autologous Platelet Transfusion (cold-stored 15 days); Drug: Aspirin; Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

  2. 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)

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

  3. 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

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

Secondary outcomes (8)

  1. 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

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

  2. 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

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

  3. 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

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

  4. CBC changes between DAPT loaded pre-transfusion, 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion, baseline

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

  5. Platelet unit blood gas: changes during storage

    during storage of the units

    Measured: day of collection, day of transfusion

  6. Platelet unit Annexin V: changes during storage

    Measured: day of collection, day of transfusion

  7. Thromboxane B2 ELISA changes between DAPT loaded pre-transfusion, 1 hour post-transfusion, 4 hour post-transfusion, 24 hour post-transfusion, baseline

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

  8. Vasodilator-stimulated phosphoprotein (VASP) changes

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2018
  2. Study start3 Dec 2018
  3. Primary completion3 Dec 2021 (estimated)
  4. Study completion3 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03787927
Sponsor's protocol ID
2018-02
Acronym
R-DAPT
Status last verified
Jul 2020
First submitted
19 Dec 2018
Last updated
14 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Miles J, Bailey SL, Obenaus AM, Mollica MY, Usaneerungrueng C, Byrne D, Fang L, Flynn JR, Corson J, Osborne B, Houck K, Wang Y, Shen Y, Fu X, Dong JF, Sniadecki NJ, Stolla M. Storage temperature determines platelet GPVI levels and function in mice and humans. Blood Adv. 2021 Oct 12;5(19):3839-3849. doi: 10.1182/bloodadvances.2021004692.

    PubMed 34478498

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous Platelet Transfusion (room-temperature-stored), Autologous Platelet Transfusion (cold-stored 5 days) and Autologous Platelet Transfusion (cold-stored 10 days) in people with Bleeding and Platelet Dysfunction Due to Drugs, run by Bloodworks at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Measured at baseline, pre-transfusion (after administration of dual anti-platelet therapy), 1 hour post-transfusion, 24 hour post-transfusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03787927, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.

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