Aprotinin in pediatric cardiac operations: a benefit in complex malformations and with high-dose regimen only.
BACKGROUND
The benefits and the current indications of aprotinin in congenital operations are not well defined. At present there are only a few studies available that have investigated a small number of patients in several heterogeneous groups of malformations.


METHODS
We investigated efficacy and safety of aprotinin in three groups of children < 15 kg, presenting with isolated ventricular septum defect (n = 60), tetralogy of Fallot (n = 52), and transposition of the great arteries (n = 56). Low-dose aprotinin regimen A1 (500,000 KIU in pump prime only) and high-dose aprotinin A2 (50,000 KIU/kg during induction of anesthesia, 50,000 KIU/kg in pump prime, and 20,000 KIU/h continuous infusion) were compared to a control group A0 (without aprotinin) regarding perioperative blood loss, transfusion requirements, and effects on the coagulation system.


RESULTS
The most common coagulation tests of aprotinin-treated patients and the platelet numbers were comparable with those of control patients preoperatively and 15 minutes after protamine administration. A significant dose-dependent reduction in fibrin-fibrinogen split products was observed at the end of cardiopulmonary bypass in the majority of aprotinin-treated patients with transposition. In patients with ventricular septum defect and Fallot, no significant difference in blood loss and transfusion requirements could be observed between patients with or without aprotinin and no difference was observed between low- and high-dose regimen. In transposition of the great arteries, high-dose aprotinin led to significant reduction of blood loss (p = 0.02) and postoperative blood transfusion (p = 0.003). Severe side effects as a result of administration of aprotinin were not observed.


CONCLUSIONS
High-dose aprotinin reduces blood loss and transfusion requirement only in complex congenital cardiac operations; therefore aprotinin cannot be recommended as a blood conservation agent in routine pediatric operations.
Clinic for Cardiovascular Surgery, University Hospital, Zürich, Switzerland. thierry.carrel@insel.ch
T P
TP
Carrel
M
M
Schwanda
P R
PR
Vogt
M I
MI
Turina
D000768:Anesthesia, General; D007611:Aprotinin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001777:Blood Coagulation / Q000187:drug effects; D016063:Blood Loss, Surgical; D001803:Blood Transfusion; D002315:Cardiopulmonary Bypass; D004305:Dose-Response Relationship, Drug; D005338:Fibrin Fibrinogen Degradation Products / Q000187:drug effects; D006330:Heart Defects, Congenital / Q000601:surgery*; D006345:Heart Septal Defects, Ventricular / Q000601:surgery; D006490:Hemostatics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D010976:Platelet Count / Q000187:drug effects; D012449:Safety; D013771:Tetralogy of Fallot / Q000601:surgery; D014188:Transposition of Great Vessels / Q000601:surgery
D005338:Fibrin Fibrinogen Degradation Products; D006490:Hemostatics; D007611:Aprotinin