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RECRUITINGPhase 4INTERVENTIONAL

Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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. 816 subjects will be randomly divided into 2 groups (group PCC and group FFP), with 408 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) hemostatic response (effective if no hemostatic interventions occurred from 60 minutes to 24 hours after treatment initiation). Adverse events and serious adverse events will be monitored as safety outcomes.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Prothrombin Complex Concentrate, Human

Four types of 4-factor prothrombin complex concentrate will be used. 1. Human Prothrombin Complex (Rongsheng Pharmaceuticals Co., Ltd.), containing 300 IU factor IX, 300 IU factor II, 120 IU factor VII, and 300 IU factor X each bottle. 2. Human Prothrombin Complex (China Resources Boya Biopharmaceutical Group Co., Ltd.), containing 400 IU factor IX, 400 IU factor II, 200 IU factor VII, and 400 IU factor X each bottle. 3. Human Prothrombin Complex (Hualan Biological Engineering, INC.), containing 300 IU factor IX, 300 IU factor II, 75 IU factor VII, and 300 IU factor X each bottle. 4. Human Prothrombin Complex (Shandong Taibang Biological Products Co., Ltd.), containing 300 IU factor IX, 300 IU factor II, 210 IU factor VII, and 300 IU factor X each bottle. When APTT is prolonged (\> 45 s) measured 20 minutes after CPB or excessive bleeding observed, patients will be given 8～15 IU/kg PCC.

DRUG

Fresh Frozen Plasma

When APTT is prolonged (\> 45 s) measured 20 minutes after CPB or excessive bleeding observed, patients will be given 6～10 mL/kg FFP.

Locations (2)

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China