About this trial
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.
Eligibility criteria
Qualifiers
• 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)
Disqualifiers
• 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.
Trial design
Treatments tested in this trial
- CSL511 Fibrinogen concentrate (human)
- Cryoprecipitate