Clinical trial NCT06617897: Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Official title: A Phase 3, Single-center, Randomized, Controlled Clinical Study to Investigate the Efficacy of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acquired Fibrinogen Deficiency
Keywords: Fibrinogen deficiency
Pseudomyxoma peritonei
Cytoreductive surgery
Hyperthermic intraperitoneal chemotherapy
Blood coagulation disorder
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: Percentage of participants with overall hemostatic success
timeFrame: During surgery to 24 hours after surgery
Secondary outcomes:
measure: Number of participants with treatment-emergent (TE): adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs)
timeFrame: Up to 30 days after IV infusion
measure: Number of participants with intraoperative hemostatic efficacy
timeFrame: During surgery
measure: Number of participants with postoperative hemostatic efficacy
timeFrame: Up to 24 hours after surgery
measure: Plasma fibrinogen concentration
timeFrame: During surgery, at the end of surgery and up to 24 hours after start of surgery
measure: Mean total dose of fibrinogen administered
timeFrame: During surgery, at the end of surgery and up to 24 hours after start of surgery
measure: Number of doses of fibrinogen administered
timeFrame: During surgery, at the end of surgery and up to 72 hours after start of surgery
measure: Duration of surgery
timeFrame: During surgery
measure: Intraoperative blood loss
timeFrame: During surgery
measure: Intraoperative requirements for blood products
timeFrame: During surgery
measure: Postoperative blood loss
timeFrame: Up to 48 hours after start of surgery
measure: Postoperative requirements for blood products
timeFrame: Up to 9 days after surgery
measure: Number of participants with reoperation (for bleeding)
timeFrame: Up to 30 days after surgery
measure: Number of participants with reoperation (for reasons other than bleeding)
timeFrame: Up to 30 days after surgery
measure: Duration of mechanical ventilation
timeFrame: Up to 30 days after surgery
measure: Duration of intensive care unit (ICU) stay
timeFrame: Up to 30 days after surgery
measure: Duration of hospital stay
timeFrame: Up to 30 days after surgery
measure: 21-day mortality
timeFrame: Up to 21 days after surgery
measure: In-hospital mortality
timeFrame: Up to 30 days after surgery
measure: Time between placing the investigational product (IP) order to administration
timeFrame: During surgery
measure: Prothrombin time and activated partial thromboplastin time
timeFrame: Up to 8 days after surgery
measure: Coagulation parameter profile
timeFrame: Up to 8 days after surgery
measure: Coagulation factor profile
timeFrame: Up to 8 days after surgery
Other outcomes:
Locations:
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire Hospital
Study officials:
affiliation: CSL Behring
name: Study Director
role: STUDY_DIRECTOR
References: