Prothrombin Complex Concentrate (PCC) vs Plasma in Post-Cardiopulmonary Bypass Coagulopathy

Prothrombin complex concentrate (PCC) is safe and efficacious to use over plasma in post-cardiopulmonary bypass (CPB) coagulopathy and bleeding cases as per a recent study published in JAMA Surgery. There were fewer posttreatment intraoperative RBC transfusions, improved PT/INR correction, and a higher likelihood to avoid allogeneic transfusion in patients receiving PCCs.

The most common reasons for blood product transfusion in surgical practices is the post-cardiopulmonary bypass (CPB) coagulopathy and bleeding. Present retrospective data show lower rates of transfusions and also blood loss in patients receiving prothrombin complex concentrate (PCC) compared with plasma after cardiac surgery. Hence, researchers conducted a study to analyze perioperative bleeding and transfusion outcomes in patients undergoing cardiac surgery who develop microvascular bleeding and receive treatment with either PCC or plasma.

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Study Design

A single-institution, prospective, randomized clinical trial was performed at a high-volume cardiac surgical center on patients who were aged 18 years or older and undergoing cardiac surgery with CPB. Patients undergoing complex cardiac surgical procedures like aortic replacement surgery, multiple procedures, or repeated sternotomy were given priority enrollment. During the study period, 756 patients were approached for enrollment, and 553 patients were randomized, and 100 patients met the criteria for study intervention. Patients with excessive microvascular bleeding, a prothrombin time (PT) greater than 16.6 seconds, and an international normalized ratio (INR) greater than 1.6 were randomized to receive treatment with either PCC or plasma. The PCC dose was 15 IU/kg or the closest standardized dose, and the plasma dose was a suggested volume of 10 to 15 mL/kg rounded to the nearest unit.

Outcomes

Postoperative bleeding from the initial postsurgical intensive care unit admission through midnight on postoperative day 1 as measured by chest tube output was the primary outcome of the measurement. Secondary outcomes were PT/INR, rates of intraoperative red blood cell (RBC) transfusion after treatment, avoidance of allogeneic transfusion from the intraoperative period to the end of postoperative day 1, postoperative bleeding, and any other adverse events.

Results

• One hundred patients with a mean [SD] age of 66.8 [13.7] years participated in the study, of which 61 were males.
• Among the total 100, there were 1 Black, 1 Hispanic, and 98 White.
• Out of the 100 participants, 49 received plasma and 51 received PCC.
• There was no significant difference in chest tube output between the plasma and PCC groups.
• After treatment, patients in the PCC arm had a greater improvement in PT (effect estimate, −1.37 seconds) and INR (effect estimate, −0.12).
• Fewer patients in the PCC group required intraoperative RBC transfusion after treatment ([13.7%] vs [30.6%]).
• Total intraoperative transfusion rates were not significantly different between groups.
• Seven of 51 patients receiving PCCs avoided allogeneic transfusion from the intraoperative period to the end of postoperative day 1 vs none of those receiving plasma.
• There were no significant differences in postoperative bleeding, transfusions, or adverse events.

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Thus, the researchers concluded from the study that prothrombin complex concentrate showed an overall safety and efficacy profile over plasma in the present clinical context.

To read the full article, click here: 10.1001/jamasurg.2022.2235

Smith MM, Schroeder DR, Nelson JA, et al. Prothrombin Complex Concentrate vs Plasma for Post-Cardiopulmonary Bypass Coagulopathy and Bleeding: A Randomized Clinical Trial. JAMA Surg. 2022;157(9):757-764.