Using CSL511 to improve blood coagulation in patients with pseudomyxoma peritonei undergoing surgery
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
PHASE3 · CSL Behring · NCT06617897
This study is testing if a new treatment called CSL511 can help patients with pseudomyxoma peritonei manage bleeding better during surgery.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CSL Behring (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Basingstoke) |
| Trial ID | NCT06617897 on ClinicalTrials.gov |
What this trial studies
This phase 3 clinical trial investigates the efficacy and safety of CSL511, a fibrinogen concentrate, in patients with pseudomyxoma peritonei who are undergoing cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy. Participants will be randomly assigned to receive either CSL511 or cryoprecipitate, with a focus on those expected to experience significant intraoperative blood loss. The study aims to determine if CSL511 can effectively manage bleeding during surgery, potentially improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with pseudomyxoma peritonei who are at high risk for intraoperative blood loss during cytoreductive surgery.
Not a fit: Patients with confirmed or suspected coagulation disorders or those who have had recent cardiovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce intraoperative bleeding and improve recovery outcomes for patients undergoing surgery for pseudomyxoma peritonei.
How similar studies have performed: Other studies have shown promise in using fibrinogen concentrates for managing bleeding in surgical settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Basingstoke
- Basingstoke and North Hampshire Hospital — Basingstoke, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Trial Registration Coordinator
- Email: clinicaltrials@cslbehring.com
- Phone: +1 610-878-4697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acquired Fibrinogen Deficiency, Fibrinogen deficiency, Pseudomyxoma peritonei, Cytoreductive surgery, Hyperthermic intraperitoneal chemotherapy, Blood coagulation disorder