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

Launched by CHINESE ACADEMY OF MEDICAL SCIENCES, FUWAI HOSPITAL · Jan 25, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether a treatment called 4-factor prothrombin complex concentrate (PCC) is effective in reducing blood loss during and after heart surgery compared to a different treatment known as fresh frozen plasma (FFP). The trial will involve around 796 patients who are scheduled for heart surgeries, such as coronary artery bypass grafting or valve replacement. Participants will be randomly assigned to receive either PCC or FFP during their surgery. The main goal is to see how much blood each group loses within 24 hours after surgery. Researchers will also look at how many red blood cell transfusions each group needs and how long they stay in the intensive care unit.

To be eligible for this trial, patients need to be between 18 and 80 years old and scheduled for specific types of heart surgery. They must also show signs of bleeding or blood clotting issues during surgery. However, patients with a history of heart surgery, certain liver conditions, serious bleeding disorders, or those taking specific blood-thinning medications may not be able to participate. Those who join the trial will be monitored closely after their surgery for up to a week to assess their recovery and any potential side effects. This study aims to find a safer and more effective way to manage blood loss in heart surgery patients.

Gender

ALL

Eligibility criteria

• 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.