Prothrombin Complex Concentrate Versus Frozen Plasma in Bleeding Adult Cardiac Surgical Patients: A Multicentre, Randomized, Active-control, Pragmatic, Phase 2 Pilot Study
试验速览
- 阶段
- 2 期
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Treatment response
研究概览
简要总结
This is a multicentre, randomized, active-control, pragmatic, Phase 2 pilot study in adult cardiac surgery patients. Two Canadian hospitals will participate, and it is estimated that the study will take approximately 9 months to complete.
Approximately 120 bleeding adult cardiac surgical patients who require coagulation factor replacement during cardiac surgery will be included. Patients will be randomized to receive either PCC or FP when the blood bank receives the first order for coagulation factor replacement and deems it to be in accordance with accepted clinical standards. Patients will be treated according to their assigned group on the first and second times when coagulation factor replacement is ordered during the treatment period (24 hours after randomization). For any additional doses (i.e., the third dose and thereafter), patients in both groups will receive FP (in 1U increments at the discretion of the ordering physician). No other aspects of care will be modified.
This pilot study aims to select a clinically relevant primary efficacy endpoint for a confirmative Phase 3 study, which will subsequently aim to determine if PCC is non-inferior or superior to FP in terms of effica-cy and safety in bleeding cardiac surgical patients. In the pilot study, safety outcomes will be measured for the first 28 days, which is the duration of participation of each patient in the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients undergoing any index cardiac surgery with or without CPB in whom coagulation factor replacement with PCC or FP is ordered in the operating room for:
- •Management of bleeding, or
- •Anticipated bleeding in a patient who has
- •been on-pump for >2 hours, or
- •undergone a complex procedure (e.g., ACB + AVR). Coagulation factor deficiency must either be known to exist (as indicated by elevated EXTEM clotting time [CT] or international normalized ratio [INR]), or be suspected based on the clinical situation.
排除标准
- •Patients who meet any of the following criteria are not eligible for the study:
- •Undergoing heart transplantation, insertion or removal of ventricular assist devices (not including intra-aortic balloon pump [IABP]), or repair of thoracoabdominal aneurysm
- •Critical state immediately before emergency surgery with high probability of death within 24 hours of surgery (e.g., acute aortic dissection, cardiac arrest within 24 hours before start of surgery)
- •History of heparin induced thrombocytopenia
- •Last preoperative INR >1.5 and patient on warfarin
- •Taken dabigatran, rivaroxaban, apixaban, or edoxaban within 48 hours of start of surgery
- •Administered PCC or FP within 48 hours before start of surgery
- •History of severe allergic reaction to PCC or FP
- •Refusal of allogeneic blood products due to religious or other reasons
- •Known pregnancy
结局指标
主要结局
Treatment response
时间窗: At 4 and 24 hours
Administration of hemostatic agents including a second dose of IMP, platelet transfusion, or surgical re-exploration
Amount of allogeneic blood products
时间窗: 24 hours after the start of surgery
Number of patients who do not receive any RBC transfusions or any allogeneic blood transfusions
时间窗: first 24 hours after the start of surgery
次要结局
未报告次要终点