A Randomized Pilot Trial Assessing the Role of Human Fibrinogen Concentrate in Decreasing Cryoprecipitate Use and Blood Loss in Infants Undergoing Cardiopulmonary Bypass

Christopher F Tirotta, Richard G Lagueruela, Apeksha Gupta, Daria Salyakina, David Aguero, Jorge Ojito, Kathleen Kubes, Robert Hannan, Redmond P Burke, Christopher F Tirotta, Richard G Lagueruela, Apeksha Gupta, Daria Salyakina, David Aguero, Jorge Ojito, Kathleen Kubes, Robert Hannan, Redmond P Burke

Abstract

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. Pediatric patients (N = 30) undergoing elective cardiac surgery were randomized to receive human fibrinogen concentrate or placebo following cardiopulmonary bypass termination. The primary endpoint was the amount of cryoprecipitate administered. 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. No clinically significant differences were identified in baseline characteristics between groups. A significantly lower volume of cryoprecipitate was administered to the treatment group during the perioperative period [median (interquartile range) 0.0 (0.0-0.0) cc/kg vs 12.0 (8.2-14.3) cc/kg; P < 0.0001] versus placebo. No difference was observed between treatment groups in blood loss, laboratory coagulation tests, use of other blood components, or incidence of adverse events. FIBTEM amplitude of maximum clot firmness values was significantly higher among patients treated with human fibrinogen concentrate versus placebo (P ≤ 0.0001). No significant differences were observed in post-drug HEPTEM, INTEM, and EXTEM results. Human fibrinogen concentrate (70 mg/kg) administered after the termination of cardiopulmonary bypass reduced the need for transfusion with cryoprecipitate in a neonate and infant patient population.ClinicalTrials.gov identifier: NCT02822599.

Keywords: Cardiac surgical procedures; Cardiopulmonary bypass; Child; Fibrinogen; Hemostasis; Infant.

Conflict of interest statement

The authors have no relevant financial or non-financial interests to disclose.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Transfusion algorithm. ROTEM rotational thromboelastometry
Fig. 2
Fig. 2
CONSORT diagram
Fig. 3
Fig. 3
Adjusted FIBTEM graphs for FIBTEM A10 (A), A20 (B), and MCF (C). *Denotes a statistically significant difference between placebo and the treatment group. Whiskers indicate the maximum and minimum range, boundaries of the box indicate 25th–75th percentiles, border within the box indicates the median, ○ or + symbols linked by lines indicate the mean, ○ or + symbols outside the range indicate outliers or single data points. A10/A20 amplitude at 10/20 min, MCF maximum clot firmness

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