Actively Recruiting
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Led by CSL Behring · Updated on 2026-03-11
90
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- • 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)
You will not qualify if you...
- • 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom, RG24 9NA
Actively Recruiting
Research Team
T
Trial Registration Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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