title: Use of Confidex to control perioperative bleeding in pediatric heart surgery: prospective cohort study.
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.
authors.affiliation: Pediatric Cardiac Intensive Care Unit, Department of Cardiology and Cardiac Surgery, Bambino Gesù Children's Hospital, IRCCS, Piazza S.Onofrio 4, 00165, Rome, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Giorni
authors.forename: Zaccaria
authors.initials: Z
authors.lastname: Ricci
authors.forename: Francesca
authors.initials: F
authors.lastname: Iodice
authors.forename: Cristiana
authors.initials: C
authors.lastname: Garisto
authors.forename: Isabella
authors.initials: I
authors.lastname: Favia
authors.forename: Angelo
authors.initials: A
authors.lastname: Polito
authors.forename: Adriano
authors.initials: A
authors.lastname: Carotti
authors.forename: Paola
authors.initials: P
authors.lastname: Cogo
mesh_terms: D001777:Blood Coagulation; D001779:Blood Coagulation Factors / Q000008:administration & dosage*; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D006348:Cardiac Surgical Procedures; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006489:Hemostatic Techniques; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D015278:Intensive Care Units, Pediatric; D008297:Male; D010865:Pilot Projects; D019106:Postoperative Hemorrhage / Q000097:blood / Q000517:prevention & control*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates