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A Randomized Pilot Trial Assessing the Role of Human Fibrinogen Concentrate in Decreasing Cryoprecipitate Use and
Christopher F Tirotta1,2, Richard G Lagueruela3,4, Apeksha Gupta5
1The Heart Program, Nicklaus Children's Hospital, Miami, FL, USA. christirotta@att.net.
Insights
Human fibrinogen concentrate significantly reduced cryoprecipitate transfusions in pediatric patients undergoing cardiopulmonary bypass. This treatment improved clot firmness without increasing blood loss or adverse events, benefiting neonates and infants.
Area of Science:
- Cardiovascular Surgery
- Hematology
- Pediatric Critical Care
Background:
- Cardiopulmonary bypass (CPB) in pediatric patients often leads to coagulopathy and increased need for blood product transfusions.
- Fibrinogen is a critical clotting factor depleted during CPB, and its replacement may mitigate bleeding complications.
Purpose of the Study:
- To evaluate the efficacy of human fibrinogen concentrate in reducing blood loss and component therapy in neonates and infants undergoing CPB.
- To assess the impact of fibrinogen concentrate on hemostasis and safety in this vulnerable patient population.
Main Methods:
- A randomized, placebo-controlled trial involving 30 pediatric patients undergoing elective cardiac surgery.
- Patients received either human fibrinogen concentrate (70 mg/kg) or placebo post-CPB.
- Primary endpoint: cryoprecipitate volume administered. Secondary endpoints: blood loss, transfusion requirements, hemostasis via laboratory tests and rotational thromboelastometry (ROTEM), and adverse events.
Main Results:
- The human fibrinogen concentrate group received significantly less cryoprecipitate (0.0 cc/kg vs 12.0 cc/kg, P < 0.0001).
- No significant differences were found in blood loss, other blood component use, or adverse events between groups.
- FIBTEM maximum clot firmness was significantly higher in the fibrinogen concentrate group (P ≤ 0.0001).
Conclusions:
- Human fibrinogen concentrate effectively reduces the need for cryoprecipitate transfusions in neonates and infants after CPB.
- Fibrinogen concentrate improves clot firmness, suggesting enhanced hemostasis, without increasing perioperative bleeding or complications.
- This intervention offers a targeted approach to managing coagulopathy in pediatric cardiac surgery patients.
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.
