A Clinical Comparison of Cold-stored and Room Temperature-stored Allogeneic Platelet Transfusions in Bleeding Adult Cardiac Surgery Patients - A Randomized Multicentre Pilot Study (PLTS-1 Study)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Feasibility Outcome 2: Adequate cold-stored platelet supply
研究概览
简要总结
PLTS-1 is a multicentre, randomized, controlled, pilot trial, using a conventional, parallel group, two-armed design at 2 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT to determine the non-inferiority of cold-stored platelets compared to conventional platelets with respect to hemostatic effectiveness (total number of allogeneic blood products transfused within 24 hours after CPB), as well as safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This will be a blinded randomized trial, with clinical personnel, patients, family members, and outcome assessors blinded to group allocation. Given that the platelets will be different temperatures (but identical in appearance), an unblinded blood bank technologist, who will not have access to the collected study data, will blind the platelets by placing them in an insulated tamper-proof container accompanied by a pair of disposable insulated gloves. The clinician(s) directly handling the product at the time of transfusion will wear the insulated gloves to prevent unblinding (simulations have shown this to be an effective strategy). The platelets will also have blinded study labels and come prepared in identical collection bags.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years old) patients undergoing elective cardiac surgery with CPB will be eligible for inclusion if they are planned to undergo at least moderately complex surgery or have a preoperative platelet count ≤150,000 x106/L (this is a group at high risk of requiring platelet transfusions post-CPB).
- •Moderately complex index surgery is defined as:
- •repair/replacement of more than one valve;
- •aorta (root/ascending/arch) replacement;
- •any combination of coronary artery bypass grafting, valve repair/replacement, or aorta (root/ascending/arch) replacement; or
- •re-do procedures consisting of a repair or revision of a prior cardiac intervention.
排除标准
- •Patients will be excluded if cold-stored platelets are not going to be available at the time of surgery or if the patient:
- •has a congenital or acquired hemostatic disorder (including platelet refractoriness due to anti-platelet and anti-human leukocyte antigen [HLA] antibodies) and/or requires specially matched platelets (including patients with anaphylaxis to blood due to Immunoglobulin A [IgA] deficiency),
- •has known contraindications to heparin, thereby excluding cases where non-reversible anticoagulants (i.e. argatroban) are used,
- •is on warfarin or direct oral anticoagulants (dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to surgery,
- •is on antiplatelet drugs within 5 days prior to surgery (excluding acetylsalicylic acid [ASA]),
- •refuses allogeneic blood products,
- •has a known pregnancy,
- •has already enrolled in this study,
- •is enrolled in another interventional clinical trial where routine care and management are altered,
- •has hemodynamic instability defined as critical care admission, vasopressor, or inotrope dependence prior to index surgery, or
- •has pre-operative requirement for, or expected post-operative dependence upon mechanical circulatory support (i.e., intra-aortic balloon pump, ventricular assist device).
研究组 & 干预措施
Intervention Group
Patients randomized to the Delayed Cold-Stored Platelet Group will receive ABO-identical buffy-coat platelets (pathogen reduced products) maintained at 22°C for up to 4 days then placed at 4°C for a minimum of 1 day (24 hours), with expiration at 14 days after collection.
干预措施: Delayed Cold-Stored Buffy Coat Platelets (Biological)
Control Group
Those randomized to the Room Temperature Platelet Group will receive ABO-identical buffy-coat platelets (pathogen reduced products) maintained at 22°C for up to 7 days (as per current standard of care).
干预措施: Room Temperature Buffy Coat Platelets (Biological)
结局指标
主要结局
Feasibility Outcome 2: Adequate cold-stored platelet supply
时间窗: through study completion, an average of 1 year.
Adequate cold-stored platelet supply (defined as appropriate product available at the time of surgery for ≥90% of patients randomized to the cold-stored platelet group).
Feasibility Outcome 1: Adequate Patient Recruitment
时间窗: through study completion, an average of 1 year.
Adequate recruitment (defined as ≥ 15% of eligible patients enrolled per centre per month to target consistent levels of enrollment).
Feasibility Outcome 3: Adequate clinician adherence to randomization assignment.
时间窗: through study completion, an average of 1 year.
Adequate clinician adherence to randomization assignment (defined as \>90% of all randomized patients are administered the assigned product).
次要结局
未报告次要终点