Status:
RECRUITING
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Lead Sponsor:
CSL Behring
Conditions:
Acquired Fibrinogen Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 29 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06617897
Start Date
October 1 2024
End Date
October 29 2027
Last Update
March 11 2026
Active Locations (1)
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1
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom, RG24 9NA