NCT07032792招募中2 期
Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Total post-treatment pRBC transfusion within 24 hours of surgery
研究概览
简要总结
Coagulopathic-induced bleeding after cardiopulmonary bypass in cardiac surgery patients is common and is associated with adverse outcomes in cardiac surgery. The hypothesis of the study is that FEIBA will be a more effective treatment than standard of care (FFP) in cardiac surgery patients who have coagulopathic-induced bleeding. This study is being conducted to determine the efficacy of FEIBA versus FFP as first line therapy in correcting coagulopathic induced microvascular bleeding in cardiac surgery patients.
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 (Participant)
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 years or above
- •Undergoing nonemergent non-coronary cardiac surgery with the use of cardiopulmonary bypass
- •Patient with microvascular bleeding requiring factor transfusion as deemed by the patient care team
排除标准
- •Contraindication to the administration of FEIBA or known anaphylactic or severe hypersensitivity reaction to FEIBA or any of its components
- •Disseminated intravascular coagulation
- •Acute thrombosis or embolism, including myocardial infarction
- •Pregnancy
- •Patients that are not able or do not want to consent for themselves
- •Patients with known coagulation disorders
- •Patients who received coronary artery bypass surgery
- •Patients who received transplants or ventricular assist devices
- •Patients on extracorporeal membrane oxygenator support
- •Patients with heparin induced thrombocytopenia
- •Patients who do not wish to receive blood products even when it is deemed medically necessary
研究组 & 干预措施
FEIBA
Experimental
干预措施: FEIBA (Drug)
FFP
Active Comparator
干预措施: FFP (Drug)
结局指标
主要结局
Total post-treatment pRBC transfusion within 24 hours of surgery
时间窗: 24 hours
次要结局
- Total pRBC transfusion after administration of study drug(From time of administration of study drug until time of discharge or up to 3 months, whichever comes first.)
- Total units of posttreatment platelet transfusion within 24 hours of surgery(24 hours)
- Total units of posttreatment cryoprecipitate transfusion within 24 hours of surgery(24 hours)
- Total units of FEIBA given within 24 hours of surgery(24 hours)
- Total units of Fresh Frozen Plasma (FFP) given within 24 hours of surgery(24 hours)
- Total mLs of chest tube output within 12 hours of surgery(12 hours)
- Incidence of adverse postoperative events(Perioperative)
- Length of intubation(Perioperative)
- Length of hospital stay(From date of hospital admission until date of discharge or up to 3 months, whichever comes first.)
- 30-day mortality(30 days)
研究者
研究点 (1)
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