Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery

Completed · Phase 3

Conditions studied: Bleeding Cardiac Surgery Patients

In brief

This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.

Key facts

Study ID

NCT05523297

Run by

Octapharma

People needed

420

Starts

2022-11-30

Expected to finish

2024-06-27

Last updated by the study team

2025-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (≥18 years old) patients undergoing any index cardiac surgery employing CPB
• Coagulation factor replacement with PCC or FP ordered in the operating room for:
• Management of bleeding, or
• Anticipated bleeding in a patient who has been on-pump for >2 hours or has undergone a complex procedure (e.g., aortocoronary bypass [ACB] plus aortic valve replacement)
• Coagulation factor deficiency, either known to exist (e.g., as indicated by elevated EXTEM clotting time [CT] or INR) or suspected based on the clinical situation
• Patients who have given written informed consent. In United States patients will provide informed consent prior to surgery. In Canada, informed consent will be obtained after surgery, in accordance with Article 3.7A of the 2018 Tri- Council Policy Statement on the Ethical Conduct for Research Involving Humans.

You may not qualify if…

• Undergoing heart transplantation, insertion or removal of ventricular assist devices (not including intra-aortic balloon pump [IABP]) or repair of thoracoabdominal aneurysm
• Critical state immediately before surgery with high probability of death within 24 hours of surgery (e.g., acute aortic dissection, cardiac arrest within 24 hours before surgery)
• Severe right heart failure (clinical diagnosis ± echocardiography)
• Known contraindications to heparin
• PCC required for reversal of warfarin or direct oral anticoagulant (DOAC; dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to or during surgery
• Known thromboembolic event (TEE) within 3 months prior to surgery
• History of severe allergic reactions to PCC or FP
• Individuals who have immunoglobulin A (IgA) deficiency with known antibodies against IgA
• Refusal of allogeneic blood products
• Known pregnancy
• Currently enrolled in other interventional clinical trials

Where it is running

• Duke University Health System — Durham, North Carolina, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Royal Columbian Hospital — New Westminster, British Columbia, Canada
• University of British Columbia and Vancouver Coastal Health Authority — Vancouver, British Columbia, Canada
• Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada
• Kingston General Hospital — Kingston, Ontario, Canada
• London Health Sciences — London, Ontario, Canada
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada
• Sunnybrook Hospital — Toronto, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada
• Quebec Laval — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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