Using CSL511 to improve blood coagulation in patients with pseudomyxoma peritonei undergoing surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.