Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469742
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2007-05-02
Brief Title:
Aprotinin in Neonates Undergoing Cardiopulmonary Bypass
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Safety Profile of Aprotinin in Neonates Undergoing Cardiopulmonary Bypass A Retrospective Chart Review
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a retrospective chart review study The purpose of this study is to review our experience at Childrens Healthcare of Atlanta in neonates receiving aprotinin We will examine the specific outcomes of renal dysfunction thrombosis and mortality
Detailed Description:
Aprotinin Trasylol Bayer Corporation Pittsburgh PA a serine protease inhibitor isolated from bovine lung is used intra-operatively during cardiac surgery to reduce bleeding It is thought to work by inhibiting the contact activation phase of the coagulation cascade reducing thrombin generation preventing fibrinolysis and attenuating cardiopulmonary bypass CPB-induced platelet dysfunctionThough the efficacy of aprotinin in reducing blood loss in adults undergoing CPB is well established its safety profile specifically its association with renal dysfunction thrombosis and long-term mortality has been questioned Although the homeostatic derangements of CPB are more significant in pediatric patients its efficacy and safety profiles in this patient population are actually less clear In children undergoing re-operative cardiac surgical procedures aprotinin has been shown to be effective in attenuating post-bypass coagulopathies and decreasing blood product exposure 4 However little information is available for neonates undergoing CPB who receive intra-operative aprotinin especially in terms of renal dysfunction and thrombosis
All neonates who underwent Cardiopulmonary Bypass surgery CPB at Childrens Healthcare of Atlanta between March 1 2004 and March 1 2007 will be candidates for this retrospective chart review Notations will be made regarding those who received aprotinin and those who did not Primary end points will include post-operative renal dysfunction need for temporary dialysis thrombosis and in-hospital mortality Post -operative renal dysfunction will be defined as a doubling of the pre-operative creatinine level within the first 72 hours after surgery Thrombosis found during the initial hospitalization will be considered significant Chart review will gather demographic data age weight and type of surgery as well as other data including CPB time aortic cross clamp time presence of regional perfusion lowest temperature on CPB time to chest closure hours with a NIRS value below 40 in the first 24 hours post-op highest recorded lactate value blood products administered in the first 24 hours post-op chest tube drainage in the first 24 hours post-op first post-op weight time to extubation and time to ICU discharge
All neonates who underwent Cardiopulmonary Bypass surgery CPB at Childrens Healthcare of Atlanta between March 1 2004 and March 1 2007 will be candidates for this retrospective chart review Notations will be made regarding those who received aprotinin and those who did not Primary end points will include post-operative renal dysfunction need for temporary dialysis thrombosis and in-hospital mortality Post -operative renal dysfunction will be defined as a doubling of the pre-operative creatinine level within the first 72 hours after surgery Thrombosis found during the initial hospitalization will be considered significant Chart review will gather demographic data age weight and type of surgery as well as other data including CPB time aortic cross clamp time presence of regional perfusion lowest temperature on CPB time to chest closure hours with a NIRS value below 40 in the first 24 hours post-op highest recorded lactate value blood products administered in the first 24 hours post-op chest tube drainage in the first 24 hours post-op first post-op weight time to extubation and time to ICU discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None