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

Phase 3RecruitingNCT06617897

CSL Behring90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acquired Fibrinogen Deficiency

Interventions

CSL511 Fibrinogen concentrate (human)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage of participants with overall hemostatic success

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).

Time frame: During surgery to 24 hours after surgery

Secondary Outcomes

Number of participants with treatment-emergent (TE): adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs)

The TE AESIs include thromboembolic events, viral transmission/seroconversion, and anaphylaxis and severe hypersensitivity/severe allergic reactions.

Time frame: Up to 30 days after IV infusion

Number of participants with intraoperative hemostatic efficacy

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).

Time frame: During surgery

Number of participants with postoperative hemostatic efficacy

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).

Time frame: Up to 24 hours after surgery

Plasma fibrinogen concentration

Time frame: During surgery, at the end of surgery and up to 24 hours after start of surgery

Mean total dose of fibrinogen administered

Time frame: During surgery, at the end of surgery and up to 24 hours after start of surgery

Number of doses of fibrinogen administered

Time frame: During surgery, at the end of surgery and up to 72 hours after start of surgery

Duration of surgery

Time frame: During surgery

Intraoperative blood loss

Time frame: During surgery

Intraoperative requirements for blood products

Blood products include fresh frozen plasma, red blood cells, and platelets.

Time frame: During surgery

Postoperative blood loss

Time frame: Up to 48 hours after start of surgery

Postoperative requirements for blood products

Blood products include fresh frozen plasma, red blood cells, and platelets.

Time frame: Up to 9 days after surgery

Number of participants with reoperation (for bleeding)