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.
• 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)
• 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.
Parallel
CSL511 Fibrinogen concentrate (human)
Biological/VaccineCSL511 will be prepared in sterile water for injection and administered as an intravenous (IV) infusion.
Cryoprecipitate
Biological/VaccineCryoprecipitate will be administered via IV infusion.
Percentage of participants with overall hemostatic success
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).
Number of participants with treatment-emergent (TE): adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs)
The TE AESIs include thromboembolic events, viral transmission/seroconversion, and anaphylaxis and severe hypersensitivity/severe allergic reactions.
Number of participants with intraoperative hemostatic efficacy
Intraoperative hemostatic efficacy will be assessed by the surgeon and anesthesiologist using an objective 4-point hemostatic efficacy scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).
Number of participants with postoperative hemostatic efficacy
Postoperative hemostatic efficacy will be assessed by a hematologist using an objective 4-point hemostatic efficacy scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).
Plasma fibrinogen concentration
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