UTRECHT, THE NETHERLANDS — Use of fibrinogen concentrate makes no significant difference in blood loss compared with placebo in patients with intraoperative bleeding during high-risk cardiac surgery, according to results of a small randomized trial.
The study was published in the February 21, 2017 issue of the Journal of the American Medical Association.
"Fibrinogen-concentrate infusion in cardiac-surgery patients with intraoperative/coagulopathic bleeding should be used with caution, as there is no effect on intraoperative blood loss. It might be effective for reducing blood loss in the postoperative (24-hour) period," Dr Süleyman Bilecen (University Medical Center Utrecht, the Netherlands) told heartwire from Medscape by email.
Bilecen and colleagues randomized 120 patients (mean age 71, 69% men) undergoing high-risk cardiac surgery at a single center between February 2011 and January 2015 to receive either fibrinogen concentrate (Hemocomplettan P, CSL Bering) or placebo.
The surgery consisted of CABG combined with valve repair or replacement in 72%; mean cardiopulmonary bypass time came to 200 minutes.
The group assessed blood loss between the intervention and closure of the chest, defining intraoperative bleeding as blood loss between 60 mL and 250 mL and greater volumes of blood loss as surgical bleeding.
Mean dose of fibrinogen concentrate upon entering intensive care came to 3.1 g (95% CI 2.7–3.1 g/L) and yielded a mean fibrinogen plasma concentration in this group of 2.3 g/L (95% CI 2.2–2.4 g/L). Plasma fibrinogen concentrations 24 hours after surgery came to 3.3 g/L (95% CI 3.2–3.5 g/L).
In the placebo group, mean fibrinogen plasma concentration at arrival at intensive care came to 1.7 g/L (95% CI 1.6–1.8 g/L), then at 24 hours after the entry into intensive care that concentration came to 3.1 g/L (95% CI 2.9–3.3 g/L).
Plasma fibrinogen concentrations continued to increase in both groups following surgery, the group writes.
There was no significant between-group difference in the amount of blood loss during the time of infusion and chest closure (fibrinogen group, median 50 mL; interquartile range [IQR] 29–100 m/L) (placebo group, median 70 mL; IQR 33–145 m/L). The group also found no significant difference after adjusting for age, sex, EuroSCORE, lowest core temperature, and cardiopulmonary bypass time.
More adverse events occurred in the fibrinogen group:
Four strokes or ischemic attacks vs two in the placebo group.
Three MIs vs one in the placebo group.
Two deaths vs none in the placebo group.
Among secondary outcomes, clinicians used fewer blood products in the fibrinogen group, compared with the control group.
"This is not a final word on the use of fibrinogen concentrate," he continued. "Lower target plasma levels should be investigated. More important, the occurrence of adverse clinical events should also be evaluated to conclude on the safety profile of fibrinogen concentrate. Its use [in combination] with other procoagulant medication has not been investigated."
CSL Bering sponsored this study and donated the study medication. The authors reported no relevant financial relationships.
Heartwire from Medscape © 2017 Medscape, LLC
Cite this: Fibrinogen Concentrate Won't Cut Blood Loss at Cardiac Surgery - Medscape - Mar 07, 2017.