1. Administration of fibrinogen concentrate in patients undergoing high-risk cardiac surgery did not significantly reduce intraoperative blood loss.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Intraoperative bleeding remains one of the most common complications in cardiac surgery. Plasma fibrinogen deficiency often develops when the ongoing blood loss is substituted with red blood cells or colloid fluids. While fibrinogen replacement therapy has gained popularity in treating the associated bleeding cardiac surgery, current evidence in the literature do not provide definitive direction on its efficacy in controlling bleeding during cardiac surgery. In this randomized, placebo-controlled, double-blind clinical trial, the impact of intravenous infusion of fibrinogen on intraoperative bleeding during cardiac surgery was measured. One hundred and twenty participants were randomized to receive either a single-dose fibrinogen concentrate (n = 60; to achieve a post-infusion plasma fibrinogen level of 2.5 g/L) or placebo (n = 60). Combined coronary artery bypass graft and valve repair comprised 72% of all procedures. Median blood loss among groups that received fibrinogen concentrate (median 50 mL) or placebo (median 70 mL) were not significantly different.
Overall, the study suggests that administration of fibrinogen concentrate in patients undergoing cardiac surgery may not result in a significant reduction in intraoperative blood loss. While more adverse events in the first 30 days were found in the group that received fibrinogen infusion, the study was not powered to detect statistically significant differences between the two groups. The effect of combined fibrinogen and other prothrombotic agents is also unknown and potentially harmful. Due to the single-center nature of the study, its results may not generalize to other care settings.
In-Depth [randomized clinical trial]: This randomized clinical trial was designed and conducted at Isala Zwolle, a large university hospital in the Netherlands. The study investigated the effectiveness of fibrinogen concentrate (Hemocomplettan P, CSL Behring) for the treatment of intraoperative bleeding during cardiac surgery, and was conducted between February 2011 and December 2014. Researchers collected data for each patient starting one day prior to surgery continuing through 30 days following surgery. Eligibility criteria included age 18 years and older and the receipt of specific cardiac surgies including combined coronary artery bypass graft (CABG) and valve repair, replacement of multiple valves, aortic root reconstruction, or reconstruction of the ascending aorta or aortic arch. The primary outcome was the volume of intraoperative blood loss. Single-dose fibrinogen was given with a post-infusion target plasma fibrinogen of 2.5 g/L.
Overall, 120 patients were randomized to fibrinogen concentrate (n = 60) and placebo (n = 60) groups. Mean age was 71 years. The most common procedure was a combined CABG and valve repair (72% of patients) with a mean cardiopulmonary bypass time was 200 minutes. Blood loss was measured from the time of fibrinogen infusion to chest closure. There was no significant difference in blood loss measured between the fibrinogen group (median, 50 mL; IQR 29-100 mL) and the control group (median, 70 mL; IQR 33-145 mL; p = 0.19). Increased adverse events were found in the fibrinogen group and these included 4 cases of stroke or transient ischemic attack (2 in control), 3 myocardial infarctions (1 in control), 2 deaths (none in control), 3 cases of renal insufficiency or failure (2 in control), and 4 cases of reoperative thoracotomy (5 in the control group).
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