NCT05111028Unknown1 期
Reversal of Aspirin Antiplatelet Therapy With Cold Stored Platelets
适应症
试验速览
- 阶段
- 1 期
- 发起方
- Bloodworks
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Glycoprotein IIb/IIIa activation at 1hr post transfusion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Glycoprotein IIb/IIIa activation at 1hr post transfusion
时间窗: 1 hour after autologous transfusion
The primary endpoint is αIIbβ3 (GPIIb-IIIa) integrin activation determined by ARU (Verify Now Aspirin \[ARUTest\]) at 1h post autologous transfusion
次要结局
- 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)
研究者
研究点 (2)
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