Prospective, Multicentre, Active-control Randomised Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Bleeding Adult Cardiac Surgical Patients

LEX-211

This is a multicentre, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. Approximately 500 patients will be randomized at approximately 12 hospitals.

2022-11-10

2024-08-01

2024-08-01

Recruiting

Early phase I

500

Inclusion Criteria: 1. Adult (≥18 years old) patients undergoing any index cardiac surgery employing CPB 2. Coagulation factor replacement with PCC or FP ordered in the operating room for: 1. Management of bleeding, or 2. 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) 3. 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 4. 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. Exclusion Criteria: 1. Undergoing heart transplantation, insertion or removal of ventricular assist devices (not including intra-aortic balloon pump \[IABP\]) or repair of thoracoabdominal aneurysm 2. 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) 3. Severe right heart failure (clinical diagnosis ± echocardiography) 4. Known contraindications to heparin 5. PCC required for reversal of warfarin or direct oral anticoagulant (DOAC; dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to or during surgery 6. Known thromboembolic event (TEE) within 3 months prior to surgery 7. History of severe allergic reactions to PCC or FP 8. Individuals who have immunoglobulin A (IgA) deficiency with known antibodies against IgA 9. Refusal of allogeneic blood products 10. Known pregnancy 11. Currently enrolled in other interventional clinical trials

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Given the physical differences in the products and the emergency nature of the intervention, attending clinicians present during the infusion of the blood products/components will not be blinded to the treatment. To minimize bias, treating clinicians will be blinded to group assignments until immediately prior to IMP infusion.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}

2024-04-11