Prothrombin complex concentrates effective option to plasma in post-CPB-mediated coagulopathy: JAMA

Minnesota: A new study found that in patients undergoing cardiac surgery, prothrombin complex concentrate (PCC) are safe with improved prothrombin time (PT)/ international normalized ratio (INR) correction, intraoperative RBC transfusions, and better avoidance of allogeneic transfusion than in patients receiving plasma. The findings of this study were published in the Journal of American Medical Association - Surgery. 

The most prevalent reasons for blood product transfusion in surgical operations are post-cardiopulmonary bypass (CPB) coagulopathy and hemorrhage. Current retrospective data implies that patients receiving prothrombin complex concentrate instead of plasma following heart surgery have decreased transfusion rates and blood loss. As a result, the purpose of this study was to examine the perioperative bleeding and transfusion outcomes in patients having cardiac surgery who develop microvascular hemorrhage and are treated with either PCC or plasma.

A single-institution, prospective, randomized clinical trial was conducted by Mark M. Smith and colleagues at a busy cardiac surgery facility. Patients had to be at least 18 years old and undergoing heart surgery with CPB. Patients having difficult cardiac surgery procedures were given priority enrolment. During the research period, 756 patients were solicited for participation, and 553 were randomly assigned. 100 of the 553 randomized patients satisfied the study intervention requirements.

Patients with severe microvascular bleeding, a prothrombin time of more than 16.6 seconds, and an international normalized ratio greater than 1.6 were randomly assigned to either PCC or plasma therapy. The PCC dosage was 15 IU/kg or the nearest standardized dose; the plasma dose was 10 to 15 mL/kg rounded to the next unit.

The key findings of this study were as follows:

1. The research intervention was given to 100 patients.

2. The difference in chest tube production between the plasma and PCC groups was not statistically significant.

3. Patients in the PCC arm improved more in terms of PT and INR after therapy.

4. After therapy, fewer patients in the PCC group required intraoperative RBC transfusion; overall intraoperative transfusion rates did not differ substantially across groups.

5. From the perioperative phase until the end of postoperative day 1, seven (13.7%) of 51 patients receiving PCCs avoided allogeneic transfusion, but none of those receiving plasma did.

6. Postoperative hemorrhage, transfusions, and adverse effects did not differ significantly.

In conclusion, the findings of this study suggest that PCCs have a similar efficacy and safety profile to plasma, with a lower rate of posttreatment intraoperative RBC transfusion, improved PT/INR correction, and a higher incidence of allogeneic transfusion avoidance in patients receiving PCCs in this clinical context.

Reference:

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. Published online June 29, 2022. doi:10.1001/jamasurg.2022.2235