NCT06617897招募中3 期
A Phase 3, Single-center, Randomized, Controlled Clinical Study to Investigate the Efficacy of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- CSL Behring
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Percentage of participants with overall hemostatic success
研究概览
简要总结
This study is a phase 3, prospective, single center, randomized, open label, controlled, parallel arm, interventional study to investigate the efficacy and safety of CSL511, in participants undergoing cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for pseudomyxoma peritonei (PMP) with predicted intraoperative blood loss of greater than or equal to (>=) 2 liter (L). Eligible participants will be randomized in a 1:1 ratio to 1 of 2 treatment arms, to receive CSL511 or cryoprecipitate.
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
- None
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
- •• Aged >= 18 years at the time of providing written informed consent.
- •• Diagnosis of PMP requiring CRS with HIPEC.
- •• Bleeding risk: Predicted intraoperative blood loss of >=2L, assessed within 60 and 100 mins after start of study surgery (assessment made before 2 L of blood is lost)
排除标准
- •• Confirmed or suspected congenital or acquired coagulation disorder or a prothrombotic disorder
- •• Myocardial infarction, acute coronary syndrome, or stroke within 2 months before study surgery.
- •• Known history of chronic hepatitis.
- •• Clopidogrel or ticagrelor administration within 5 days before study surgery.
- •• Prasugrel administration within 7 days before study surgery.
- •• Oral factor Xa inhibitor administration within 2 days before study surgery.
- •• Glycoprotein IIb / IIIa antagonist administration within 24 hours before study surgery.
- •• Oral direct thrombin inhibitor administration within 3 days before study surgery.
- •• Vitamin K antagonists within 5 days before study surgery.
研究组 & 干预措施
CSL511
Experimental
干预措施: CSL511 Fibrinogen concentrate (human) (Biological)
Cryoprecipitate
Active Comparator
干预措施: Cryoprecipitate (Biological)
结局指标
主要结局
Percentage of participants with overall hemostatic success
时间窗: During surgery to 24 hours after surgery
Overall hemostatic success will be assessed by an independent data monitoring and efficacy adjudication committee (IDMEAC). The IDMEAC will assess the overall efficacy based on a composite of intraoperative and postoperative hemostasis using a 4-point scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).
次要结局
- Coagulation parameter profile(Up to 8 days after surgery)
- Coagulation factor profile(Up to 8 days after surgery)
- Number of participants with treatment-emergent (TE): adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs)(Up to 30 days after IV infusion)
- Number of participants with intraoperative hemostatic efficacy(During surgery)
- Number of participants with postoperative hemostatic efficacy(Up to 24 hours after surgery)
- Plasma fibrinogen concentration(During surgery, at the end of surgery and up to 24 hours after start of surgery)
- Mean total dose of fibrinogen administered(During surgery, at the end of surgery and up to 24 hours after start of surgery)
- Number of doses of fibrinogen administered(During surgery, at the end of surgery and up to 72 hours after start of surgery)
- Duration of surgery(During surgery)
- Intraoperative blood loss(During surgery)
- Intraoperative requirements for blood products(During surgery)
- Postoperative blood loss(Up to 48 hours after start of surgery)
- Postoperative requirements for blood products(Up to 9 days after surgery)
- Number of participants with reoperation (for bleeding)(Up to 30 days after surgery)
- Number of participants with reoperation (for reasons other than bleeding)(Up to 30 days after surgery)
- Duration of mechanical ventilation(Up to 30 days after surgery)
- Duration of intensive care unit (ICU) stay(Up to 30 days after surgery)
- Duration of hospital stay(Up to 30 days after surgery)
- 21-day mortality(Up to 21 days after surgery)
- In-hospital mortality(Up to 30 days after surgery)
- Time between placing the investigational product (IP) order to administration(During surgery)
- Prothrombin time and activated partial thromboplastin time(Up to 8 days after surgery)
研究者
研究点 (1)
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