In this double-blinded, placebo-controlled, multicenter trial, 409 cardiac surgical patients at moderate risk for transfusion were randomized to receive an intravenous dose of recombinant FXIII, 17.5 IU/kg (n?=?143), 35 IU/kg (n?=?138), or placebo (n?=?128) after cardiopulmonary bypass. Transfusion guidelines were standardized. The primary efficacy outcome was avoidance of allogeneic blood products for 7 days postsurgery. Secondary outcomes included amount of blood products transfused and reoperation rate. Serious adverse events were measured for 7 weeks.
Study groups had comparable baseline characteristics and an approximately 40 % decrease in FXIII levels after cardiopulmonary bypass. Thirty minutes postdose, FXIII levels were restored to higher than the lower 2.5th percentile of preoperative activity in 49 % of the placebo group, and 85 % and 95 % of the 17.5- and 35-IU/kg recombinant FXIII groups, respectively (P?<?.05 for both treatments vs placebo). Transfusion avoidance rates were 64.8 % , 64.3 % , and 65.9 % with placebo, 17.5 IU/kg, and 35 IU/kg recombinant FXIII (respective odds ratios against placebo, 1.05 [95 % confidence interval, 0.61-1.80] and 0.99 [95 % confidence interval, 0.57-1.72]). Groups had comparable adverse event rates.
Replenishment of FXIII levels after cardiopulmonary bypass had no effect on transfusion avoidance, transfusion requirements, or reoperation in moderate-risk cardiac surgery patients ( identifier: ).