Heparin and the Reduction of Thrombosis (HART) Trial

Study Overview
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Brief Summary
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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
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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%.

Official Title
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Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery

Conditions
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Thrombosis

Intervention / Treatment
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* Drug: Heparin sulfate infusion at 10 units/kg/hour
* Drug: Placebo infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital & #xA Exclusion Criteria: Known coagulopathy History of clinically significant bleeding (GI, cranial, pulmonary) Need for therapeutic heparinization ECMO

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study drug<br>Heparin sulfate infusion at 10 units/kg/hour | Drug: Heparin sulfate infusion at 10 units/kg/hour<br>* Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery<br>* Other names: heparin;|
| Placebo Comparator: Placebo<br>Placebo - normal saline infusion | Drug: Placebo infusion<br>* Infusion of normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis | Echocardiographic evidence of thrombosis while on study drug | While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total PRBCs Transfused |  | While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) | 
| Days to Extubation |  | While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) | 
| Cardiac ICU Length of Stay |  | While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) | 
| Need for Antibiotics |  | While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first) |