Reversal of Aspirin Antiplatelet Therapy With Cold Stored Platelets

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Reversal of Platelet Aggregation Inhibitors

In brief

Purpose of this study is to compare the reversal responses of 4°C cold stored platelets (CSP) versus 7 day, 22°C room temperature stored platelets (RTP) when given to healthy adult subjects who have received a loading dose of aspirin antiplatelet therapy.

Key facts

Study ID

NCT05111028

Run by

Bloodworks

People needed

10

Starts

2020-11-20

Expected to finish

2021-11-01

Last updated by the study team

2021-11-08

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject feels healthy and well
• 18-59 years old
• All sexes
• Temperature <99.6 F
• Resting blood pressure: systolic <181 mmHg, diastolic <101 mmHg
• Resting heart rate: 40 - 100 beats per minute
• Weight: >109 lb
• Hematocrit: >34% for female subjects, >37% for male subjects. <56% for all subjects.
• 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 significantly affect platelet function throughout their study participation determined by PI
• 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 study visits

You may not qualify if…

• Active acute infection or suspected active infection or taking antibiotics.
• 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.
• 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 or currently prescribed antiplatelet therapies [such as clopidogrel (Plavix), ticlopidine (Ticlid) or Ticagrelor (Brilinta)] and/or anticoagulant therapies [such as heparin, enoxaparin (Lovenox), warfarin (Coumadin), apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa), rivaroxaban (Xarelto)].
• 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 significantly affect platelet function within 14 days prior to screening as determined by PI.
• Chronic NSAID therapy.
• Chronic steroid therapy.
• Known allergy to aspirin.
• 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.
• Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment

Where it is running

• Bloodworks Northwest Research Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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