Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery, Compared With Fresh Frozen Plasma: Study Protocol for a Non-inferiority, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 476
- 试验地点
- 4
- 主要终点
- volume of blood loss within 24 hours after surgery
研究概览
简要总结
This non-inferiority, randomized controlled trial aims to evaluate whether coagulation-guided low-dose four-factor prothrombin complex concentrate (PCC) is non-inferior to fresh frozen plasma (FFP) in reducing cumulative chest tube drainage from 1 hour after trial drug administration to 24 hours after surgery in patients undergoing valvular heart surgery.
详细描述
Patients undergoing elective valvular heart surgery who develop post-cardiopulmonary bypass coagulation factor deficiency will be enrolled in this study. Participants will be randomly assigned to one of two groups: the PCC group or the FFP group.
Intervention: Patients in the PCC group will receive 8-15 IU/kg four-factor prothrombin complex concentrate, while those in the FFP group will receive 6-10 mL/kg fresh frozen plasma, guided by coagulation monitoring results.
The primary hypothesis is that coagulation-guided low-dose PCC is non-inferior to FFP in reducing cumulative chest tube drainage between 1 hour after trial drug administration and 24 hours after surgery.
The secondary hypotheses are that PCC provides better haemostasis and reduces the number of red blood cell units transfused between 1 hour after trial drug administration and 24 hours after surgery, as well as within 7 days postoperatively.
This study is designed to provide evidence on whether coagulation-guided low-dose PCC can serve as an effective and safe alternative to FFP in managing post-cardiopulmonary bypass coagulopathy during valvular heart 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Allocation is concealed with a secure web-based system which investigators access only after patients meet the criteria for post-CPB coagulation factor deficiency.Research nurses at each centre who are not involved in patient care or follow-up prepared equal volumes of trial medications. Opaque brown syringes and infusion tubing labelled "trial drug" are provided to anaesthesiologists when consenting participants meet eligibility criteria. Consequently, all patients, members of the healthcare team, and outcome assessors are fully blinded to treatment allocation. In emergency situations, such as rapid deterioration in a participant's clinical conditions, anaesthesiologists could adjust the infusion rate or discontinue the study medication. Unmasking could also be requested if deemed necessary for clinical management.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years.
- •Undergoing elective valve repair, valve replacement or complex valvular surgery through CPB.
- •Signing of the informed consent form.
- •A combined assessment of plasma activated partial thromboplastin time (plasma-aPTT) and activated clotting time (ACT) is performed 20 minutes after heparin neutralization following CPB. We considered patients who meet the following criteria to have post-CPB coagulation factor deficiencies: (1) at least moderate bleeding, as determined using a validated bleeding severity scale; (2) a targeted ACT within ±10% of baseline; and (3) a plasma-aPTT exceeding 45 seconds or more than 1.5 times baseline. The requirement could be waived when bleeding was severe and required immediate intervention.
排除标准
- •History of cardiac surgery.
- •Severe hepatic and renal dysfunction before surgery.
- •Coagulopathy before surgery, including inherited or acquired coagulation factor deficiencies, thrombocytopenia, platelet dysfunction and other bleeding disorders.
- •Patients undergoing emergency surgery in whom discontinuation of anticoagulant therapy was not feasible [INR > 1.2（or above upper normal limit）after discontinued use of warfarin; withdrawal of clopidogrel less than 5 days and low molecular weight heparin less than 12 hours before surgery, etc].
- •Allergy to allogeneic blood products.
- •Other serious diseases that may affect patient survival time, such as cancers.
研究组 & 干预措施
PCC group
When APTT is prolonged (> 45 s) measured 20 minutes after CPB or excessive bleeding observed, patients will be given 8～15 IU/kg PCC.
干预措施: Prothrombin Complex Concentrate, Human (Drug)
FFP group
When APTT is prolonged (> 45 s) measured 20 minutes after CPB or excessive bleeding observed, patients will be given 6～10 mL/kg FFP.
干预措施: Fresh Frozen Plasma (Drug)
结局指标
主要结局
volume of blood loss within 24 hours after surgery
时间窗: postoperative period up to 24 hours after surgery
the volume of drainage within 24 hours after surgery
次要结局
- total units of allogeneic RBCs transfused within 7 days after surgery(during the intraoperative and postoperative period up to 7 days after surgery)
- hemostatic response(from 60 minutes to 24 hours after treatment initiation)
研究者
SHI Jia
Vice Chair, the department of Anesthesiology
Chinese Academy of Medical Sciences, Fuwai Hospital