Acquired Fibrinogen Deficiency

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

NCT06617897 | PHASE 3 | INTERVENTIONAL

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.

0 Sites

90 Participants

Recruiting

18 Years to 11 Years

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Study 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 (eg, von Willebrand's disease, hemophilia, or severe liver disease) or a prothrombotic disorder (eg, protein C or S deficiency, or heparin induced thrombocytopenia).
* Myocardial infarction, acute coronary syndrome, or stroke within 2 months before study surgery.
* Positive viral serology for hepatitis A virus, hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus (HIV)-1/2, or parvovirus B19 at the Screening Visit.
* 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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov