Aprotinin is safe in pediatric patients undergoing cardiac surgery

Backer, Carl L.; Kelle, Angela M.; Stewart, Robert D.; Suresh, Sunitha C.; Ali, Farah; Cohn, Richard A.; Seshadri, Roopa; Mavroudis, Constantine

doi:10.1016/j.jtcvs.2007.08.006

Cited by 56 publications

(45 citation statements)

References 23 publications

(21 reference statements)

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“…Aprotinin, a basic polypeptide and non-specific proteinase inhibitor, can inhibit several proteases with serine active groups. Recently, aprotinin became no longer restricted to the treatment of patients with acute pancreatitis; it is being used more and more in cardiac surgeries, orthopedic surgeries and liver transplantations [25,26] , and is considered the ideal blood protecting drug.…”

Section: Discussionmentioning

confidence: 99%

Requirements for transfusion and postoperative outcomes in orthotopic liver transplantation: A meta-analysis on aprotinin

Liu¹,

Chen²,

Wang³

2008

WJG

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INTRODUCTIONOrthotopic liver transplantation (OLT) has become the first choice approach for the treatment of patients with end-stage liver diseases [1] . However, despite great improvements in graft preservation, surgical skills, anesthetic techniques and perioperative management [2,3] , OLT is still associated with severe bleeding and considerable transfusion requirements, which in turn greatly contribute to the peri-operative morbidity and mortality [4] . Severe bleeding in OLT occurs for several reasons, among which hemostatic abnormalities remain a major cause [5,6] . Aprotinin, a serine protease inhibitor, is more and more commonly being used in surgeries, such as cardiac surgeries and liver transplantations, to reduce bleeding and the need for transfusions. A meta-analysis of 12 trials (n = 626) of children undergoing cardiac surgery demonstrated aprotinin reduced the proportion of children receiving b l o o d t r a n s f u s i o n s d u r i n g c a r d i a c s u r g e r y w i t h cardiopulmonary bypass, but had no significant effect on the volume of blood transfused or on the amount of chest tube drainage [7] . Similarly, a meta analysis of 13 trials (n = 506) of patients undergoing major orthopedic surgery demonstrated the pooled blood loss and the amounts of red blood cell (RBC) units (U) transfused intraoperatively and peri-operatively were significantly lower among aprotinin-treated patients than control patients. Moreover, aprotinin was not associated with an increased incidence Abstract AIM: To study the effect of aprotinin used in orthotopic liver transplantation (OLT) on the intraoperative requirement for blood products and on the incidence of laparotomy for bleeding, thrombotic events and mortality.

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Section: Discussionmentioning

confidence: 99%

Requirements for transfusion and postoperative outcomes in orthotopic liver transplantation: A meta-analysis on aprotinin

Liu¹,

Chen²,

Wang³

2008

WJG

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“…Although off-label use of aprotinin was common among congenital heart surgeons, high-quality studies were lacking. [466][467][468] The FDA has never approved a specific pediatric indication for aprotinin, and with the 2007 restrictions, it is no longer available for pediatric cardiac surgery in the United States.…”

Section: Prevention and Treatment Of Postoperative Coagulopathymentioning

confidence: 99%

Prevention and Treatment of Thrombosis in Pediatric and Congenital Heart Disease

Giglia¹,

Massicotte²,

Tweddell³

et al. 2013

Circulation

283

245

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“…aprotinin, although in children it has been not reported significant adverse effects as noted in adults [11][12][13], and associated with the fact that there is little information available about its influence on the systemic inflammatory response at hemostatic doses, these considerations have led to this study, which aimed to show hemostatic benefit with the use of aprotinin in high doses in acyanotic cardiopathic children operated with CPB by assessing the possible anti-inflammatory effect associated, which was not confirmed in this series.…”

Section: Fig 6 -Il-6/il10 Proportion In the Aprotinin And Control Grmentioning

confidence: 71%

“…However, in recent retrospective cohort studies of children who had undergone surgery with CPB, there was no association between use of aprotinin and renal failure, dialysis, neurologic complications and mortality [11], and reported that the CPB time over 100 minutes was the main marker of postoperative renal dysfunction in neonates but not the use of the drug, which was not associated with this risk in the immediate postoperative period [12,13]. The use of safety data in adults for pediatric practice requires caution and is of questionable validity, since they are two distinct populations with distinct risk factors, and drugs that have the greatest risk of complications in adults can be safe in children, and vice versa.…”

Section: Introductionmentioning

confidence: 98%

Avaliação da aprotinina na redução da resposta inflamatória sistêmica em crianças operadas com circulação extracorpórea

Ferreira¹,

Vicente²,

Évora³

et al. 2010

Rev Bras Cir Cardiovasc

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Avaliação da aprotinina na redução da resposta inflamatória sistêmica em crianças operadas com circulação extracorpóreaAssessment of aprotinin in the reduction of inflammatory systemic response in children undergoing surgery with cardiopulmonary bypass Abstract Objective: To assess if the hemostatic high-dose aprotinin is able to reduce the inflammatory process after cardiopulmonary bypass (CPB) in children.Methods: A prospective randomized study was performed on children aged 30 days to 4 years who underwent correction of acyanogenic congenital heart disease with CPB and were divided into two groups: Control (n=9) and Aprotinin (n=10). In the Aprotinin Group the drug was administered before and during CPB and the systemic inflammatory response and hemostatic and multiorgan dysfunctions were assessed through clinical and biochemical markers. Differences were considered to be significant when P<0.05.Results: The groups were similar regarding demographic and intraoperative variables, except for a greater hemodilution in the Aprotinin Group. The drug had no benefit regarding time of mechanical pulmonary ventilation, staying in the postoperative ICU and length of hospitalization, or regarding the use of inotropic drugs and renal function. The partial arterial oxygen pressure/ inspired oxygen fraction ratio (PaO 2 /FiO 2 ) was significantly reduced 24 h after surgery in the Control Group. Blood loss was similar for both groups. Significant leukopenia was observed in the Aprotinin Group during CPB, followed by leukocytosis. Tumor necrosis factor alpha (TNF-á), interleukins (IL)-6, IL-8, IL-10, IL-6/IL-10 ratio did not differ significantly between groups. The postoperative IL-6/IL-10 ratio increased significantly in the Control Group. There were no complications with the use of aprotinin.Conclusion: In this study, hemostatic high-dose aprotinin did not minimize the clinical manifestations or serum markers of the inflammatory systemic response. Descriptors 86FERREIRA, CA ET AL -Assessment of aprotinin in the reduction of inflammatory systemic response in children undergoing surgery with cardiopulmonary bypass Bras Cir Cardiovasc 2010; 25(1): 85-98 Rev

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Aprotinin is safe in pediatric patients undergoing cardiac surgery

Cited by 56 publications

References 23 publications

Requirements for transfusion and postoperative outcomes in orthotopic liver transplantation: A meta-analysis on aprotinin

Requirements for transfusion and postoperative outcomes in orthotopic liver transplantation: A meta-analysis on aprotinin

Prevention and Treatment of Thrombosis in Pediatric and Congenital Heart Disease

Avaliação da aprotinina na redução da resposta inflamatória sistêmica em crianças operadas com circulação extracorpórea

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