Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT00779558
Status:
COMPLETED
Last Update Posted:
2015-06-12
First Post:
2008-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Heparin and the Reduction of Thrombosis (HART) Trial
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2015-06
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:
Heparin is frequently used in central venous catheters (CVCs) in post-operative cardiac patients. It remains unclear if a heparin infusion, compared to a normal saline infusion, prevents thrombosis of CVCs after surgery. This study will answer the question: does a low-dose heparin infusion (10 units/kg/h) prevent thrombosis, compared to a normal saline infusion, in patients less than one year of age after cardiac surgery?
Detailed Description:
Patients are contacted pre-operatively and their parents consented. The following criteria apply:
Inclusion criteria:
All infants \< 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital
Exclusion Criteria:
Known coagulopathy History of clinically significant bleeding (GI, cranial, pulmonary) Need for therapeutic heparinization ECMO
Randomization and blinding are performed in the Pharmacy. The intervention is initiated at the intensive care unit physician's discretion, generally within the 1st 24 hours post-operatively. The study is terminated when all catheters have been discontinued or at POD #14, whichever occurs first.
Thrombosis is demonstrated by echocardiogram or ultrasound performed at
1 - 3 days, 5 - 7 days, and 10 - 14 days after initiation of the study drug.
The following are calculations for statistical analysis:
Sample size determination - Using 2 - sided alpha = 0.05 and Beta = 0.2, and assuming a baseline thrombosis incidence of 20%, 160 patients are required to detect an effect size of 15%.
Inclusion criteria:
All infants \< 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital
Exclusion Criteria:
Known coagulopathy History of clinically significant bleeding (GI, cranial, pulmonary) Need for therapeutic heparinization ECMO
Randomization and blinding are performed in the Pharmacy. The intervention is initiated at the intensive care unit physician's discretion, generally within the 1st 24 hours post-operatively. The study is terminated when all catheters have been discontinued or at POD #14, whichever occurs first.
Thrombosis is demonstrated by echocardiogram or ultrasound performed at
1 - 3 days, 5 - 7 days, and 10 - 14 days after initiation of the study drug.
The following are calculations for statistical analysis:
Sample size determination - Using 2 - sided alpha = 0.05 and Beta = 0.2, and assuming a baseline thrombosis incidence of 20%, 160 patients are required to detect an effect size of 15%.
Study Oversight
Has Oversight DMC:
False
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?: