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NCT Number: NCT06617897

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

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.

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Key information

Conditions

Acquired Fibrinogen Deficiency Adenocarcinoma Adenocarcinoma, Mucinous Afibrinogenemia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Carcinoma Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Glandular and Epithelial Pseudomyxoma Peritonei

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Basingstoke and North Hampshire Hospital

Basingstoke, RG24 9NA, United Kingdom

Location status: Recruiting

Location contact

Asoke Roy

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CSL511 Fibrinogen concentrate (human)

Biological

CSL511 will be prepared in sterile water for injection and administered as an intravenous (IV) infusion.

Cryoprecipitate

Biological

Cryoprecipitate will be administered via IV infusion.

Primary outcomes

  1. Percentage of participants with overall hemostatic success

    Time frame: 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 outcomes

  1. 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

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

  2. Number of participants with intraoperative hemostatic efficacy

    Time frame: 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).

  3. Number of participants with postoperative hemostatic efficacy

    Time frame: 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).

  4. Plasma fibrinogen concentration

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

  5. Mean total dose of fibrinogen administered

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

  6. Number of doses of fibrinogen administered

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

  7. Duration of surgery

    Time frame: During surgery

  8. Intraoperative blood loss

    Time frame: During surgery

  9. Intraoperative requirements for blood products

    Time frame: During surgery

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

  10. Postoperative blood loss

    Time frame: Up to 48 hours after start of surgery

  11. Postoperative requirements for blood products

    Time frame: Up to 9 days after surgery

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

  12. Number of participants with reoperation (for bleeding)

    Time frame: Up to 30 days after surgery

  13. Number of participants with reoperation (for reasons other than bleeding)

    Time frame: Up to 30 days after surgery

  14. Duration of mechanical ventilation

    Time frame: Up to 30 days after surgery

  15. Duration of intensive care unit (ICU) stay

    Time frame: Up to 30 days after surgery

  16. Duration of hospital stay

    Time frame: Up to 30 days after surgery

  17. 21-day mortality

    Time frame: Up to 21 days after surgery

  18. In-hospital mortality

    Time frame: Up to 30 days after surgery

  19. Time between placing the investigational product (IP) order to administration

    Time frame: 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.

  20. Prothrombin time and activated partial thromboplastin time

    Time frame: Up to 8 days after surgery

  21. Coagulation parameter profile

    Time frame: 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.

  22. Coagulation factor profile

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Registration Coordinator

CONTACT

[email protected]

+1 610-878-4697

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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