Fibrinogen Concentrate to Cardiac Surgery Patients with Ongoing Bleeding does not Increase the Risk of Thromboembolic Complications or DeathFunding This study was supported by research grants from the Department of Research & Development, Skaraborg Hospital, Skövde, Sweden, the Local Research and Development Council, Skövde, Sweden; Department of Anaesthesiology and Intensive Care Medicine, Sahlgrenska University Hospital/Östra, Gothenburg, Sweden, the Swedish Heart-Lung Foundation, and Region Västra Götaland, Gothenburg, Sweden.
15 September 2019
15 November 2019
15 January 2020 (online)
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.
K.W. planned the study, collected and analysed the data and wrote the report. A.J. planned the study, analysed the data and reviewed the report. S.N. performed the statistical analyses and reviewed the report. M.K. planned the study, analysed the data and reviewed the report. The study was planned and executed, data were collected and analysed, and the manuscript was independently written by the authors only.
To the best of our knowledge, the use of fibrinogen concentrate to treat acquired hypofibrinogenaemia is off label use in the United States, but is or have been registered for this indication in some European countries.
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