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Recruiting NCT06617897

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

Phase III Interventional Acquired Fibrinogen Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CSL511 Fibrinogen concentrate (human), Cryoprecipitate.
Who it may be relevant to
Registry conditions: Acquired Fibrinogen Deficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

Interventions

  • Biological CSL511 Fibrinogen concentrate (human)
    CSL511 will be prepared in sterile water for injection and administered as an intravenous (IV) infusion.
  • Biological Cryoprecipitate
    Cryoprecipitate will be administered via IV infusion.

Primary outcome measures

  • Percentage of participants with overall hemostatic success [Time frame: During surgery to 24 hours after surgery]
Secondary outcome measures (12)
  • Number of participants with treatment-emergent (TE): adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs) [Time frame: Up to 30 days after IV infusion]
  • Number of participants with intraoperative hemostatic efficacy [Time frame: During surgery]
  • Number of participants with postoperative hemostatic efficacy [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 [Time frame: During surgery]
  • Postoperative blood loss [Time frame: Up to 48 hours after start of surgery]
  • Postoperative requirements for blood products [Time frame: Up to 9 days after surgery]
  • Number of participants with reoperation (for bleeding) [Time frame: Up to 30 days after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Basingstoke and North Hampshire Hospital — Basingstoke

Identifiers

NCT: NCT06617897 · CSL511_3003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗