Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery, Compared With Fresh Frozen Plasma: Study Protocol for a Non-inferiority, Randomized Controlled Trial

PCC vs FFP Study

This study is a non-inferiority, randomized controlled trial, based on the hypothesis that 4-factor PCC is not inferior to FFP in reducing perioperative blood loss in patients undergoing cardiac surgery under cardiopulmonary bypass. 796 subjects will be randomly divided into 2 groups (group PCC and group FFP), with 398 cases in each group. Patients will be given 8\~15 IU/kg 4-factor PCC in group PCC and 6\~10 ml/kg FFP in group FFP. All the patients will be followed up respectively at 24 hours, 48 hours, 72 hours and 7 days after the surgery. The primary outcome is the volume of blood loss within 24 hours after surgery. The secondary outcomes include (1) the total units of allogeneic red blood cells (RBCs) transfused within 7 days after surgery and (2) length of intensive care unit (ICU) stay. Adverse events and serious adverse events will be monitored as safety outcomes. Exploratory outcomes include re-exploration due to postoperative bleeding within 7 days after surgery and length of hospital stay.

2023-12-01

2025-08-31

2025-12-31

Not yet recruiting

Early phase I

796

Inclusion Criteria: 1. Age between 18 and 80 years. 2. Undergoing elective coronary artery bypass grafting (CABG) or valve replacement or valvuloplasty through CPB. 3. Signing of the informed consent form. 4. Developing coagulation factor deficiency or coagulopathic bleeding during the surgery, meeting the indications of PCC or FFP treatment: a) prolonged APTT (\> 45 s) measured 20 minutes after CPB, and b) excessive bleeding observed. Exclusion Criteria: 1. History of cardiac surgery. 2. Severe hepatic dysfunction before surgery. 3. Coagulopathy before surgery, including inherited or acquired coagulation factor deficiencies, thrombocytopenia, platelet dysfunction and other bleeding disorders. 4. Use of warfarin and INR \> 1.2 before surgery. 5. Withdrawal of clopidogrel less than 5 days and low molecular weight heparin less than 12 hours before surgery. 6. Allergy to allogeneic blood products. 7. Pregnancy. 8. Other serious diseases that may affect patient survival time, such as cancers.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '796 patients who meet the criteria will be randomly divided into 2 groups, named prothrombin complex concentrate group (group PCC) and fresh frozen plasma group (control group, group FFP), with 398 cases in each group. Preoperative management, anesthetic and surgical techniques will be standardized for all patients. Prolonged APTT (\\> 45 s) will be regarded as a trigger for administration of PCC or FFP, according to the randomized groups. In group PCC, patients will be given 8\\~15 IU/kg PCC. In group FFP, patients will be given 6\\~10 mL/kg FFP.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Allocation will be concealed using an interactive web response system, and nurse anaesthetists will prepare the corresponding products for each patient according to the group assignments in an anaesthesia preparation room. PCC or FFP will be pumped into 50 ml syringes firstly, covered with opaque paper to hide the contents. For group PCC, we first diluted PCC to 50ml with normal saline, and then supplemented subsequent volume using normal saline to make it equal to the corresponding required volume of FFP.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 796, 'type': 'ESTIMATED'}}

2023-11-15