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Use of Confidex to control perioperative bleeding in pediatric heart surgery: prospective cohort study
Chiara Giorni1, Zaccaria Ricci, Francesca Iodice
1Pediatric Cardiac Intensive Care Unit, Department of Cardiology and Cardiac Surgery, Bambino Gesù Children's Hospital, IRCCS, Piazza S.Onofrio 4, 00165, Rome, Italy.
Insights
Prothrombin complex (Confidex) effectively reduced postoperative bleeding in infants undergoing cardiac surgery. This treatment proved safe, decreasing the need for blood transfusions without significant side effects.
Area of Science:
- Pediatric Cardiac Surgery
- Hematology
- Anesthesiology
Background:
- Postoperative bleeding is a significant complication in pediatric cardiac surgery.
- Nonsurgical bleeding in infants undergoing cardiac surgery requires effective management strategies.
Purpose of the Study:
- To evaluate the safety and efficacy of prothrombin complex (Confidex) in infants with nonsurgical bleeding after cardiac surgery.
- To assess the impact of Confidex on postoperative bleeding and transfusion requirements.
Main Methods:
- Prospective cohort study matching 14 infants who received Confidex with 11 control infants.
- Administration of Confidex bolus after cardiopulmonary bypass in the treatment group.
- Comparison of preoperative coagulation profiles, intra- and postoperative transfusion needs, and clinical outcomes.
Main Results:
- Confidex group showed significantly less postoperative bleeding (0.0 vs. 1.9 ml/kg/h).
- Fewer patients in the Confidex group required packed red blood cells postoperatively (14% vs. 54%).
- No anaphylaxis or thrombotic events observed; coagulation parameters did not differ significantly.
Conclusions:
- Prothrombin complex (Confidex) is safe and effective for managing nonsurgical bleeding in infants post-cardiac surgery.
- Confidex reduces postoperative bleeding and the need for red blood cell transfusions.
- The study supports Confidex as a valuable therapeutic option in this patient population.
Abstract:
Bleeding during and after cardiac surgery is a major issue in pediatric patients. A prospective cohort study was conducted to evaluate the effect of a commercially available prothrombin complex (Confidex) administered in cardiac surgery after weaning from cardiopulmonary bypass of infants with nonsurgical bleeding. In this study, 14 patients younger than 1 year received a Confidex bolus and were matched with 11 patients of a similar age who did not receive the drug. The preoperative coagulation profile was similar in the two groups. No side effects, including anaphylaxis or thrombotic events, were observed. The numbers of units of packed red blood cells and fresh frozen plasma administered both intra- and postoperatively were similar. The postoperative coagulation examination results and thromboelastographic parameters did not differ significantly between the two groups. However, the Confidex patients bled significantly less than the control subjects during the first 24 postoperative hours. The median volume of drained blood was 0.0 ml/kg h (range 0-1.9 ml/kg h) compared with 1.9 ml/kg h (range 1-3 ml/kg h) (p = 0.009). At least one unit of packed red blood cells in the postoperative phase was required by 2 patients (14 %) in the Confidex group and six patients (54 %) in the control group (odds ratio [OR], 0.13; 95 % confidence interval [CI], 0.02-0.9; p = 0.03). The median duration of mechanical ventilation was 3 days (range 2-4 days) in the Confidex group and 4 days (range 0-8 days) in the control group (p = 0.66). The median stay in the intensive care unit was 6 days (range 5-9 days) in the Confidex group and 7 days (range 4-12 days) in the control group (p = 0.88). The use of Confidex for infants undergoing cardiac surgery was safe and effective. It reduced postoperative bleeding and allowed fewer units of packed red blood cells to be infused in the postoperative phase without major side effects.