CSL511 Fibrinogen concentrate (human): CSL511 will be prepared in sterile water for injection and administered as an intravenous (IV) infusion.
Cryoprecipitate: Cryoprecipitate will be administered via IV infusion.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* • 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)
Exclusion Criteria:
* • 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.
Primary outcome measure(s)
Percentage of participants with overall hemostatic success — 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).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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