Reversal of Aspirin Antiplatelet Therapy With Cold Stored Platelets

NCT05111028 | Unknown Phase 1 FDA Drug

• 1 other identifier: 2020-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Reversal of Platelet Aggregation Inhibitors

Keywords

Aspirin; Blood Platelets; Platelet Aggregation Inhibitors; Platelet Transfusion

Outcome Measures

Primary Outcomes (1)

• Glycoprotein IIb/IIIa activation at 1hr post transfusion

  The primary endpoint is αIIbβ3 (GPIIb-IIIa) integrin activation determined by ARU (Verify Now Aspirin \[ARUTest\]) at 1h post autologous transfusion

  1 hour after autologous transfusion

Secondary Outcomes (2)

• Glycoprotein IIb/IIIa activation at 4hr post transfusion

  4 hours after autologous transfusion

• Glycoprotein IIb/IIIa activation at 24hr post transfusion

  24 hours after autologous transfusion

Study Arms (2)

Period 1

ACTIVE COMPARATOR

Each research subject will participate in two study periods that will crossover from one storage product to the other storage product (Cold Stored Platelets vs Room Temperature Platelets) based on the randomization assignment. In Period 1 subjects will undergo an apheresis platelet collection, aspirin dosing, transfusion of their autologous platelets, and followed by platelet response testing and safety assessments. This is repeated in Period 2 using the other storage product. CSP is the the experimental comparator and RTP is the active comparator.

Biological: Autologous Room Temperature stored Platelet transfusion; Biological: Autologous Cold Stored Platelet transfusion

Period 2

EXPERIMENTAL

Each research subject will participate in two study periods that will crossover from one storage product to the other storage product (Cold Stored Platelets vs Room Temperature Platelets) based on the randomization assignment. In Period 1 subjects will undergo an apheresis platelet collection, aspirin dosing, transfusion of their autologous platelets, and followed by platelet response testing and safety assessments. This is repeated in Period 2 using the other storage product. CSP is the the experimental comparator and RTP is the active comparator.

Biological: Autologous Room Temperature stored Platelet transfusion; Biological: Autologous Cold Stored Platelet transfusion

Interventions

Autologous Room Temperature stored Platelet transfusion BIOLOGICAL

An autologous transfusion of platelets stored at 22°C for 7 days.

Period 1; Period 2

Autologous Cold Stored Platelet transfusion BIOLOGICAL

An autologous transfusion of platelets stored at 4°C for 7, 14, 21, or 28 days.

Period 1; Period 2

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject feels healthy and well
• 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.

Sponsors & Collaborators

• Bloodworks: lead
• United States Department of Defense: collaborator

Study Sites (1)

Bloodworks Northwest Research Institute

Seattle, Washington, 98102, United States

Location

Study Officials

• Moritz Stolla, MD, PhD

  Bloodworks

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: November 20, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)