Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
- Conditions
- Acquired Fibrinogen Deficiency
- Interventions
- Biological: CSL511 Fibrinogen concentrate (human)Biological: Cryoprecipitate
- Registration Number
- NCT06617897
- Lead Sponsor
- CSL Behring
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CSL511 CSL511 Fibrinogen concentrate (human) - Cryoprecipitate Cryoprecipitate -
- Primary Outcome Measures
Name Time Method Percentage of participants with overall hemostatic success During surgery to 24 hours after surgery Overall hemostatic success will be assessed by an independent data monitoring and efficacy adjudication committee (IDMEAC). The IDMEAC will assess the overall efficacy based on a composite of intraoperative and postoperative hemostasis using a 4-point scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).
- Secondary Outcome Measures
Name Time Method Coagulation parameter profile Up to 8 days after surgery The following coagulation parameter profiles will be assessed: thrombin generation marker, protein C and S, antithrombin and alpha 2-antiplasmin.
Coagulation factor profile Up to 8 days after surgery The following coagulation factor profiles will be assessed: fibrinogen, factor VIII (FVIII):C, von Willebrand ristocetin cofactor (VWF:Rco) and factor XIII (FXIII).
Duration of mechanical ventilation Up to 30 days after surgery Duration of intensive care unit (ICU) stay Up to 30 days after surgery Duration of hospital stay Up to 30 days after surgery Number of participants with treatment-emergent (TE): adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs) Up to 30 days after IV infusion The TE AESIs include thromboembolic events, viral transmission/seroconversion, and anaphylaxis and severe hypersensitivity/severe allergic reactions.
Number of participants with intraoperative hemostatic efficacy During surgery Intraoperative hemostatic efficacy will be assessed by the surgeon and anesthesiologist using an objective 4-point hemostatic efficacy scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).
Number of participants with postoperative hemostatic efficacy Up to 24 hours after surgery Postoperative hemostatic efficacy will be assessed by a hematologist using an objective 4-point hemostatic efficacy scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).
Plasma fibrinogen concentration During surgery, at the end of surgery and up to 24 hours after start of surgery Mean total dose of fibrinogen administered During surgery, at the end of surgery and up to 24 hours after start of surgery Number of doses of fibrinogen administered During surgery, at the end of surgery and up to 72 hours after start of surgery Duration of surgery During surgery Intraoperative blood loss During surgery Intraoperative requirements for blood products During surgery Blood products include fresh frozen plasma, red blood cells, and platelets.
Postoperative blood loss Up to 48 hours after start of surgery Postoperative requirements for blood products Up to 9 days after surgery Blood products include fresh frozen plasma, red blood cells, and platelets.
Number of participants with reoperation (for bleeding) Up to 30 days after surgery Number of participants with reoperation (for reasons other than bleeding) Up to 30 days after surgery 21-day mortality Up to 21 days after surgery In-hospital mortality Up to 30 days after surgery Time between placing the investigational product (IP) order to administration During surgery The following time to event parameters will be assessed: time between when IP is ordered and when IP is ready to administer in the operating room and time between when IP is ordered and start of IP administration.
Prothrombin time and activated partial thromboplastin time Up to 8 days after surgery
Trial Locations
- Locations (1)
Basingstoke and North Hampshire Hospital
🇬🇧Basingstoke, United Kingdom