In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Clot Degradation at 24 Hours Post-operatively
研究概览
简要总结
This primary aim of this study is to compare the in vivo effects of fibrinogen concentrate and cryoprecipitate on the neonatal fibrin network after surgery with cardiopulmonary bypass to develop effective and safe strategies for managing coagulopathies in neonates.
详细描述
This study is a prospective, randomized control trial comparing two different sources of fibrinogen on clot kinetics (degradation and structure) in post-CPB coagulopathy in neonates undergoing cardiac surgery. The two sources of fibrinogen include the blood product, cryoprecipitate, and a blood product alternative, fibrinogen concentrate. Cryoprecipitate is an allogenic blood product that requires cross-matching and thawing prior to administration and is associated with immunologic reactions and possible pathogen transmission. Fibrinogen concentrate, a blood product alternative, is a purified form of fibrinogen, which undergoes a pasteurization process to minimize the risk of immunologic and allergic reactions. The primary aim of this study is compare the in vivo effect of post-CPB administration of FC, a blood product alternative, to cryoprecipitate on neonatal clot properties and clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full term neonates (36-42 weeks gestational age)
- •Infants =< 30 days of age at time of surgery
- •APGAR score of 6 or greater at 5 minutes after delivery
- •Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta
- •Parents willing to participate and able to understand and sign the provided informed consent
排除标准
- •Preterm neonates (less than 36 weeks gestation)
- •Patients undergoing an emergent procedure or surgery not requiring CPB
- •Patients with personal or family history of a coagulation defect or coagulopathy
- •Parents unwilling to participate or unable to understand and sign the provided informed consent
研究组 & 干预措施
Fibrinogen Concentrate (FC)
Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who are randomized to receive platelets and FC after separation from bypass. The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.
If a patient in either arm continues to have post-bypass bleeding, the anesthesiologist will use point of care testing and the transfusion thresholds outlines in the transfusion algorithm to determine appropriate products for transfusion.
干预措施: Fibrinogen Concentrate (FC) (Drug)
Cryoprecipitate
Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who are randomized to receive platelets and cryoprecipitate. Standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 286mg/dL (based on findings by Downey et al., published in Anesthesia and Analgesia in 2020).
If a patient in either arm continues to have post-bypass bleeding, the anesthesiologist will use point of care testing and the transfusion thresholds outlines in the transfusion algorithm to determine appropriate products for transfusion.
干预措施: Cryoprecipitate (Drug)
结局指标
主要结局
Clot Degradation at 24 Hours Post-operatively
时间窗: From induction of anesthesia to 24 hours postoperatively
Blood samples were obtained from an arterial line that was required for the planned surgical procedure. Samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Clot degradation was determined by degradation kinetic study. Blood samples were collected at four time points:1) baseline sample within 24 hours of surgery and after induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1 hour of separation from bypass; 3) upon arrival to the ICU; 4) 24 hours post-operatively. The primary outcome is to examine differences in clot degradation between study arms at 24 hours post-surgery.
次要结局
- Interoperative Transfusion Requirement(During surgery (up to 6 hours))
- Length of Hospital Stay(At discharge from hospital (up to 150 days))
- Amount of Post-operative Bleeding(Up to 24 hours postoperatively)
- Clot Polymerization Kinetic(From induction of anesthesia to 24 hours postoperatively)
- Clot Strength(From induction of anesthesia to 24 hours postoperatively)
- Transfusion Requirements Within the First 24 Hours After Surgery(24 hours postoperatively)
- Mechanical Ventilation Time(Time of extubation (up to 2 weeks))
- Length of ICU Stay(At discharge from ICU (typically up to 21 days))
- Number of Adverse Events(Within seven days of surgery)
- Fibrin Fiber Alignment(From induction of anesthesia to 24 hours postoperatively)
研究者
Laura A Downey
Associate Professor
Emory University