No significant differences were observed in post-drug HEPTEM, INTEM, and EXTEM results. FIBTEM amplitude of maximum clot firmness values was significantly higher among patients treated with human fibrinogen concentrate versus placebo ( P ≤ 0.0001). No difference was observed between treatment groups in blood loss, laboratory coagulation tests, use of other blood components, or incidence of adverse events. A significantly lower volume of cryoprecipitate was administered to the treatment group during the perioperative period versus placebo. No clinically significant differences were identified in baseline characteristics between groups.
Secondary endpoints included estimated blood loss during the 24 h post-surgery perioperative blood product transfusion effects of fibrinogen infusion on global hemostasis, measured by laboratory testing and rotational thromboelastometry and adverse events. The primary endpoint was the amount of cryoprecipitate administered. Pediatric patients ( N = 30) undergoing elective cardiac surgery were randomized to receive human fibrinogen concentrate or placebo following cardiopulmonary bypass termination. The objective of this study was to determine whether treatment with human fibrinogen concentrate decreases the need for component blood therapy and blood loss in neonate and infant patients undergoing cardiopulmonary bypass.
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