Fibrinogen Concentrate to Cardiac Surgery Patients with Ongoing Bleeding does not Increase the Risk of Thromboembolic Complications or Death.

BACKGROUND: We investigated whether fibrinogen concentrate administration to bleeding patients is associated with an increased risk of thromboembolic complications and death. METHODS: All consecutive patients who underwent first-time cardiac surgery at Sahlgrenska University Hospital from 2009 to 2014 were included. Patients, who had received fibrinogen concentrate, were compared with those who had not received fibrinogen concentrate. The primary endpoint was a composite of thromboembolic complications and death within 1 year after surgery. Secondary endpoints included the composite and mortality within 30 days and mortality within 1 year after surgery. Multivariable logistic regression and Cox regression models were used to compare the groups. Propensity score (PS)-matched models were used for sensitivity analyses. RESULTS: A total of 5,408 patients were included in the present study, of which 564 (10.4%) received fibrinogen concentrate. The composite endpoint occurred in 3.5% of patients at 30 days and 10.5% at 1 year. There was no significant difference between the groups in the composite endpoint at 1 year (adjusted hazard ratio [HR]: 1.11, 95% confidence interval [CI]: 0.84-1.46, p = 0.45) or in the secondary endpoints, that is, mortality at 1 year (adjusted HR: 1.38, 95% CI: 0.93-2.04, p = 0.11), composite at 30 days (adjusted odds ratio [OR]: 1.07, 95% CI: 0.64-1.81, p = 0.79) and mortality at 30 days (adjusted OR: 1.00, 95% CI: 0.51-1.96, p = 0.50). The results of the sensitivity analyses were consistent with those of main analyses. CONCLUSION: Perioperative administration of fibrinogen concentrate to bleeding cardiac surgery patients is not associated with an increased risk of thromboembolic complications or death.

Low preoperative fibrinogen plasma concentration is associated with excessive bleeding after cardiac operations.

BACKGROUND: Data from small selected patient populations suggest that the preoperative plasma concentration of fibrinogen influences postoperative blood loss and red blood cell transfusion after cardiac operations, but there are also conflicting reports. We assessed the importance of preoperative fibrinogen concentration for excessive bleeding and red cell blood transfusion in a large cohort of mixed cardiac surgical patients. METHODS: We included 1,954 cardiac surgical patients in a prospective observational study. The fibrinogen plasma concentration was measured on the day before the operation. Blood loss (mediastinal drain volume) during the first 12 postoperative hours and red blood cell transfusion during the hospital stay were registered and related to fibrinogen concentration with logistic regression models. Excessive bleeding was defined as postoperative blood loss exceeding 1,000 mL/12 hours. RESULTS: The preoperative fibrinogen concentration was inversely proportional to the prevalence of excessive bleeding in univariate testing (odds ratio [OR], 0.75; 95% confidence interval [CI], 0.64 to 0.89 per g/L; p=0.001) and also in a multiple model adjusted for age, sex, body mass index, renal function, acuteness of the operation, cardiopulmonary bypass time, clopidogrel use less than 5 days before the operation, and type of operation (OR for fibrinogen, 0.82; 95% CI, 0.69 to 0.97; p=0.024). In contrast, the prevalence of red cell blood transfusion increased with increasing fibrinogen levels in univariate testing (OR, 1.36; 95% CI, 1.24 to 1.49; p<0.001) but not in a multiple model (OR, 1.10; 95% CI, 0.89 to 1.28; p=0.49). CONCLUSIONS: Preoperative plasma concentration of fibrinogen is independently associated with excessive bleeding after cardiac operations but not with red blood cell transfusion.