Activated Prothrombin Complex Concentrate FEIBA to Optimize Postcardiopulomonary Bypass Hemostasis in Pediatric Cardiac Patients
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Number of units of allogeneic blood products required early perioperatively in pediatric cardiac patients.
研究概览
简要总结
The purpose of this research is to understand if the medication called FEIBA helps to stop bleeding and decrease transfusion of blood products to small children operated on the heart.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight ≤ 15 kg.
- •Elective cardiac surgery with cardiopulmonary bypass.
- •Coagulopathic bleeding after cardiopulmonary bypass.
- •Availability and willingness of the parent/legal guardian to provide informed consent.
排除标准
- •Presence of mechanical circulatory support at the time of randomization or POD 0 and
- •Patient or family history of coagulopathy and/or thromboses.
- •Preoperative anticoagulation (excluding low dose heparin for "line prophylaxis").
研究组 & 干预措施
FEIBA Group
Pediatric patients ≤15 kg of weight, undergoing cardiac surgery with cardiopulmonary bypass will receive activated prothrombin complex concentrate (aPCC) FEIBA to be incorporated into standard treatment of post-bypass coagulopathic bleeding.
干预措施: FEIBA (Drug)
Placebo Group
Pediatric patients ≤15 kg of weight, undergoing cardiac surgery with cardiopulmonary bypass will receive a placebo to be incorporated into standard treatment of post-bypass coagulopathic bleeding.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of units of allogeneic blood products required early perioperatively in pediatric cardiac patients.
时间窗: approximately 1 day postoperatively
Number of units of transfused allogeneic blood products after cardiopulmonary bypass in the operating room (OR) and in the intensive care unit (ICU) on postoperative day (POD) 0 and 1.
次要结局
- Hospital length of stay(Through hospital discharge, approximately 3 days)
- Mortality(Through hospital discharge, approximately 3 days)
- Intravascular and intracardiac thromboses(approximately 3 days postoperatively)
研究者
Elena Ashikhmina
Principal Investigator
Mayo Clinic