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

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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. 560 subjects will be randomly divided into 2 groups (group PCC and group FFP), with 280 cases in each group. Patients will be given a 4-factor PCC based on the patients' body weight and INR in group PCC and a dose of 10-15 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 during and within 24 hours after surgery. The secondary outcomes include (1) the total units of allogeneic red blood cells (RBCs) transfused during and within 7 days after surgery and (2) re-exploration due to postoperative bleeding within 7 days after surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Collaborator: Peking Union Medical College Hospital
• Treatments: Thrombin

Criteria

Inclusion Criteria:

1. Receiving elective coronary artery bypass grafting (CABG), or valve replacement or valvuloplasty with cardiopulmonary bypass

2. Sign the informed consent

Exclusion Criteria:

1. History of cardiac surgery;

2. Hepatic dysfunction;

3. Renal insufficiency (serum creatinine higher than 176 µmol/l);

4. Severe coagulopathy;

5. Withdrawal of clopidogrel or aspirin less than 7 days and low molecular weight heparin less than 24 hours before surgery;

6. Hematological disorders;

7. Mass blood transfusion 24 hours before surgery;

8. Allergy to allogeneic blood products;

9. Pregnancy;

10. Other serious diseases that may affect patient survival time, such as tumors.