Auto-PLTS: The Effectiveness of Autologous, Cold-stored Platelets Collected 7-10 Days Before Cardiac Surgery for Avoidance of Allogeneic Transfusions: A Randomized Patient Preference Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
The Auto-PLTS Study is a single-centre trial performed at Toronto General Hospital (TGH) that uses a randomized, patient preference design. The recent introduction of cold-stored platelets with a shelf-life of 14 days into clinical practice has made it possible to offer autologous apheresis platelet predonation to patients undergoing elective cardiac (and other high-blood-loss) surgeries while allowing sufficient time to recover platelet count before surgery. The Auto-PLTS Study is designed to assess whether replacing allogeneic platelets with autologous platelets will improve patient outcomes and benefit the healthcare system by reducing the burden on allogeneic platelet supply. The study is also designed to determine whether patients are willing to donate autologous platelets 7-10 days prior to surgery.
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
- Single (Outcomes Assessor)
盲法说明
All safety outcomes will be collected by blinded research staff and reviewed by blinded assessors.
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 who meet all following criteria:
- •Undergoing elective complex cardiac surgery consisting of at least one of the following:
- •Repair or replacement of more than one valve (i.e., multiple valves)
- •Repair or replacement of any segment of aortic arch
- •At least two of any combination of coronary artery bypass grafting (CABG), valve repair/replacement, or aorta (ascending/arch) repair/replacement
- •Complex adult congenital repair
排除标准
- •Patients who meet any of the following criteria are not eligible for the study:
- •Seven days or less from recruitment to surgery (as there will not be sufficient time from platelet donation to surgery for patients to recover their platelet count)
- •Patient factors that preclude platelet donation or increase risk of adverse events after donation, including any of the following:
- •Poor intravenous access
- •Low baseline platelet count (≤150,000 x106/L)
- •Low baseline hemoglobin (<100 g/L) (since approximately 50 mL of red blood cells are lost with each unit of apheresis platelet collection)
- •Inability to tolerate fluid shifts during donation (i.e., severe aortic stenosis with valve area <0.7 cm2, or left main coronary artery stenosis >80%, or left ventricular ejection fraction <30%)
- •Increased risk of bacterial contamination of collected units (i.e., active infection, on antibiotics, dental procedure <72 hours before donation)
- •Attending clinicians deem the patient ineligible for autologous predonation
- •Known positivity for active infectious blood-borne disease (HIV, HCV, HBV, HTLV, Syphilis)
- •Highly specialized procedures such as insertion or removal of ventricular assist devices or repair of thoracoabdominal aneurysm
- •Any history of congenital or acquired bleeding disorder (including any type of thrombocytopenia or platelet refractoriness due to anti-platelet and anti-HLA antibodies or requirement for specially matched platelets)
- •On any anticoagulant or antiplatelet medications, excluding ASA, that cannot be stopped at least 7 days before donation (72 hours for NSAIDs)
- •Refusal of allogeneic blood products due to religious or other reasons
- •Known or suspected pregnancy
研究组 & 干预措施
Intervention Group
Patients in the intervention group will undergo autologous collection of 2 units of apheresis platelets 7-10 days before surgery during their preadmission visit. The collected autologous platelets will be cold-stored at 1-6°C until the time of surgery. Patients will receive their own autologous platelets during or after surgery in response to excessive bleeding in the setting of low platelet count or function.
干预措施: Autologous Cold-Stored Platelets (Biological)
Control Group
Patients in the control group will receive standard, Health Canada approved, allogeneic platelets supplied by the Canadian Blood Services (stored at room temperature for up to 7 days) during or after surgery in response to excessive bleeding in the setting of low platelet count or function.
干预措施: Allogeneic Room Temperature-Stored Platelets (Standard of Care) (Biological)
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: up to 24 hours after termination of cardiopulmonary bypass (CPB)
The incidence of allogeneic platelet transfusion during the treatment period
次要结局
未报告次要终点