Randomized Clinical Trial of Fibrin Sealant in Cardiac Surgery Patients Undergoing Resternotomy or Reoperation: A Multicenter Study

Abstract

A multicenter study was conducted to test the efficacy and safety of fibrin sealant (FS) as a topical hemostatic agent in patients undergoing either reoperative cardiac surgery (redo) or emergency resternotomy. A total of 333 patients from 11 centers in the United States were included in the study. Patients were randomly assigned to initially receive FS or a conventional topical hemostatic agent when such was required during surgery. The end-point used to evaluate the agent’s efficacy was local hemostasis, recording the number of bleeds controlled within 5 min The FS group from the prospective study was compared to historical matched controls for postoperative blood loss, need for resternotomy, blood products received, and hospital stay and to historical nonmatched controls for incidence of resternotomy and mortality. The results showed a 92.6% success rate for FS in controlling bleeding within 5 min of application, compared to only 12.4% success with conventional topical agents (p < 0.001). FS also rapidly controlled 82.0% of those bleeds not initially controlled by conventional agents. High-volume postoperative blood loss was significantly less (p < 0.05) in the FS group vs. matched controls. Additionally, resternotomy rates in redos were significantly lower in the FS group (5.6%) compared to nonmatched historical controls (10%; p = 0.0089). There were no significant differences in hospital stay or blood products received between FS and matched historical controls and no difference in mortality between the FS group and nonmatched historical controls. There were no documented adverse reactions, transmission of viral infection (hepatitis B, non-A/non-B hepatitis), or HIV seroconversion. This study shows that FS is safe and highly effective in controlling localized bleeding in cardiac operations. FS reduces postoperative blood loss and decreases the incidence of emergency resternotomy. These findings make FS a valuable hemostatic agent in cardiac surgery.