Status: Recruiting
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
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.
Participants needed: 90
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: CSL BehringUpdated: Mar 11, 2026Locations: 1
Eligibility criteria
• Aged >= 18 years at the time of providing written informed consent. [+2]
• Confirmed or suspected congenital or acquired coagulation disorder or a prothr... [+8]