Comparing 4F‑PCC (BE1116) and fresh frozen plasma to treat bleeding during complex heart surgery with cardiopulmonary bypass

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 is a phase 3, multicenter, randomized, open‑label, parallel‑group controlled study comparing BE1116 (4F‑PCC) with fresh frozen plasma (FFP) in adults undergoing complex cardiovascular surgery with cardiopulmonary bypass (CPB). Eligible participants are adults having elective complex procedures requiring CPB who develop bleeding and for whom coagulation factor replacement is ordered intraoperatively. Treatment is given in the operating room after protamine reversal when point‑of‑care INR criteria are met, and patients are randomized to receive BE1116 or FFP. The study's primary focus is on correcting coagulation factor deficiencies and monitoring safety outcomes between the two groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult greater than or equal to (≥) 18 years and has provided written informed consent.
* Undergoing elective complex cardiovascular surgery requiring CPB, including procedures of the thoracic aorta (with or without additional cardiac interventions), aortic valve replacement + coronary artery bypass graft (CABG), complex valve surgeries, mitral valve repair + CABG, and mitral valve replacement + CABG and reoperative CABG. Reoperative procedures are permitted. Excluded surgeries are as follows: heart transplantation, insertion or removal of ventricular assist devices (except for intra-aortic balloon pumps), and acute repair of thoracoabdominal aneurysms.
* Coagulation factor replacement (ie, 4F-PCC or FFP) is ordered in the operating room for the management of bleeding, in accordance with accepted clinical standards. The following criteria must be met:
* INR ≥ 1.6 (point-of-care INR testing by Hemochron ≥ 5 to 10 minutes after protamine infusion for heparin reversal). If a participant needs a second dose of protamine, a new INR measurement should be performed to confirm eligibility.
* Significant microvascular hemorrhage (ie, not due to surgical complications), as defined by a BSS score of ≥ 2.

Exclusion Criteria:

* Administration of any systemic hemostatic therapy, such as cryoprecipitate, platelets, FFP, PCC (eg, 4-factor / 3-factor PCC \[4F-PCC / 3F-PCC\]), Factor VIII (FVIII) inhibitor bypassing activity (FEIBA), recombinant activated Factor VIIa (rFVIIa), or other coagulation factor products, in the 24 hours before study surgery, except when FFP is added to the CPB circuit.

Where it's running

• UCLA Health - Ronald Reagan Medical Center
  Los Angeles, California, United States Recruiting
• University of Chicago Medicine
  Chicago, Illinois, United States Recruiting
• University of Maryland Medical Center (UMMC)
  Baltimore, Maryland, United States Recruiting
• University of Cincinnati
  Cincinnati, Ohio, United States Recruiting
• OUHSC (University of Oklahoma Health Sciences Center)
  Oklahoma City, Oklahoma, United States Recruiting
• Oregon Health & Sciences University
  Portland, Oregon, United States 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.