Abstract
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.
Keywords
cardiac surgery - fibrinogen concentrate - bleeding - thromboembolism - mortality