The use of recombinant coagulation factor VIIa in uncontrolled postoperative bleeding in children undergoing cardiac surgery with cardiopulmonary bypass.
OBJECTIVE
To assess the hemostatic efficacy of recombinant coagulation factor VIIa (rFVIIa) in the management of uncontrolled bleeding in postcardiac surgery with cardiopulmonary bypass in children.


METHODS
An open-label study.


METHODS
A postoperative intensive care unit.


METHODS
Eight consecutive pediatric patients with excessive bleeding after cardiac surgery with cardiopulmonary bypass that met the criteria for reexploration and did not respond to optimal transfusions of platelets and fresh frozen plasma.


METHODS
rFVIIa 30 microg/kg was given as a bolus injection. A higher dose of 60 microg/kg was used if a patient had preoperative coagulopathy, preoperative multiple-organ failure, or indications that required an emergency operation. The same dose was repeated 15 mins after the previous injection if the bleeding had not decreased. If the bleeding had decreased but still exceeded 10 mL/hr for body weight </=5 kg or exceeded 2 mL.kg(-1).hr(-1) for body weight >5 kg, the same dose was repeated 2 hrs after the previous injection. A maximum of four doses could be given before rFVIIa was considered ineffective and a reexploration was needed.


RESULTS
Postoperative blood loss was estimated from the volume of chest tube drainage. rFVIIa successfully controlled bleeding and prevented reexploration in all seven patients who received treatment according to the protocol. One patient who received only one dose of rFVIIa required reexploration because a second dose was not available. No adverse events related to rFVIIa were seen.


CONCLUSIONS
rFVIIa may be useful in preventing reexploration in uncontrolled postoperative bleeding in children undergoing cardiac surgery with cardiopulmonary bypass. Randomized, placebo-controlled studies are needed to confirm the safety and efficacy of rFVIIa in this clinical setting.
Pychyńska-Pokorska
Magdalena
M
Department of Anesthesiology and Intensive Care, Polish Mother Memorial Hospital Research Institute, Łódź, Poland.
Moll
Jacek Jan
JJ
Krajewski
Wojciech
W
Jarosik
Piotr
P
D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D002315:Cardiopulmonary Bypass / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D005167:Factor VII / Q000627:therapeutic use*; D015942:Factor VIIa; D005260:Female; D005340:Fibrinogen / Q000378:metabolism; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010314:Partial Thromboplastin Time; D010976:Platelet Count; D019106:Postoperative Hemorrhage / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D011517:Prothrombin Time; D011994:Recombinant Proteins / Q000627:therapeutic use*
D006490:Hemostatics; D011994:Recombinant Proteins; D005167:Factor VII; D005340:Fibrinogen; C103587:recombinant FVIIa; D015942:Factor VIIa