No reduction in intraoperative bleeding with fibrinogen concentrate
medwireNews: Results of a randomized trial published in JAMA suggest that infusion of fibrinogen concentrate does not reduce intraoperative blood loss during high-risk cardiac surgery.
“Because of fibrinogen’s key role in maintaining hemostasis and because it is rapidly depleted during cardiac surgery, fibrinogen replacement therapy has gained popularity in treating cardiac surgery-associated bleeding,” say Süleyman Bilecen (University Medical Center Utrecht, the Netherlands) and study co-authors.
However, the team found no significant difference in blood loss among patients receiving fibrinogen compared with placebo, at a median of 50 mL versus 70 mL.
In their randomized, double-blind trial, the researchers assigned 120 patients who experienced intraoperative bleeding to receive infusion with placebo or fibrinogen concentrate (Hemocomplettan P, CSL Behring, USA), dosed to achieve a plasma fibrinogen level of at least 2.5 g/L, after completion of cardiopulmonary bypass (CBP). Blood loss was measured between infusion of the study drug and chest closure.
Almost three-quarters of the study participants underwent coronary artery bypass grafting surgery combined with valve repair or replacement surgery, whereas 18% underwent thoracic aorta surgery, and 10% valve surgery.
The mean age of the patients was 70 years in the fibrinogen group and 72 years in the placebo group; a corresponding 27% and 32% had diabetes, and the mean duration of CBP was 209 minutes and 192 minutes, respectively.
The lack of significant difference in bleeding rates among patients receiving fibrinogen versus placebo remained after multivariable adjustment for factors including age, gender, EuroSCORE, core temperature, and CBP time, and the results were consistent in a sensitivity analysis taking missing data into account.
Although post-hoc exploratory analyses indicated that patients in the fibrinogen group experienced significantly lower rates of cumulative blood loss in the first 24 hours after surgery compared with those in the placebo group (570 vs 690 mL), the authors note that “this difference was less than the minimal clinically important difference anticipated for this study and, therefore, not clinically relevant.”
Patients receiving fibrinogen experienced more adverse events within 30 days of surgery than those receiving placebo, including stroke (6.7 vs 1.7%) and myocardial infarction (5.0 vs 1.7%). There were no deaths in the placebo group, but two (3.3%) patients in the fibrinogen group died.
“In general, this study had a high-risk patient population; patients were older, had a high incidence of diabetes mellitus, and had long durations of cardiopulmonary bypass, which might explain the large number of adverse events,” believe the authors.
Bilecen and team say that conducting their study at a single center “reduced the potential for variability in the study and adherence to the study protocol,” but they concede that the findings “may not generalize to other care settings.”
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