Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery

Launched by CSL BEHRING · Sep 27, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called CSL511 for patients with pseudomyxoma peritonei (PMP) who are about to undergo a type of surgery known as cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC). The study aims to find out if CSL511 is effective and safe for patients who might lose a lot of blood during surgery. Participants in the trial will be randomly assigned to receive either CSL511 or a standard treatment called cryoprecipitate, which is a blood product used to help with bleeding.

To be eligible for this study, participants must be at least 18 years old and have been diagnosed with PMP that requires CRS and HIPEC. They should also be expected to lose at least 2 liters of blood during the surgery. However, individuals with certain blood disorders or recent serious health issues, such as heart attacks or strokes, will not be able to join the trial. If you or a loved one qualifies and participates, you can expect close monitoring during the study to ensure safety and gather important information about the treatment's effects.

Gender

ALL

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.