Using Prothrombin Complex Concentrate to Reduce Blood Loss in Heart 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

This study is testing whether a treatment called prothrombin complex concentrate can help reduce blood loss during heart surgery compared to a standard treatment called fresh frozen plasma.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 820 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (Academic / other)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT04244981 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of prothrombin complex concentrate (PCC) compared to fresh frozen plasma (FFP) in minimizing blood loss during cardiac surgeries that require cardiopulmonary bypass. A total of 796 patients undergoing elective coronary artery bypass grafting or valve procedures will be randomly assigned to receive either PCC or FFP. The primary outcome measured will be the volume of blood loss within the first 24 hours post-surgery, while secondary outcomes will assess the total units of red blood cells transfused and the length of ICU stay. Safety and exploratory outcomes will also be monitored throughout the follow-up period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 undergoing elective cardiac surgeries like CABG or valve replacement who develop coagulation issues during the procedure.

Not a fit: Patients with a history of cardiac surgery, severe hepatic dysfunction, or pre-existing coagulopathy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to reduced blood loss and lower transfusion rates during cardiac surgeries, improving patient outcomes.

How similar studies have performed: Previous studies have shown promising results with similar interventions, but this specific comparison of PCC and FFP in cardiac surgery is relatively novel.

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC — Beijing, Beijing Municipality, China (Recruiting)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jia Shi, M.D. — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Shi Jia, M.D.

Conditions Cardiac Surgical Procedures; prothrombin complex concentrate; fresh frozen plasma; perioperative blood loss; efficacy; cardiac surgery; cardiopulmonary bypass