Heparin and the Reduction of Thrombosis (HART) Trial
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Purpose
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?
| Condition | Intervention |
|---|---|
|
Thrombosis |
Drug: Heparin sulfate infusion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Heparin and Catheter-Related Thrombosis in Neonates and Infants Following Cardiac Surgery |
- Thrombosis
- Number of blood transfusions
- Days to extubation
- Cardiac ICU length of stay
- Need for antibiotics
- Laboratory values (coagulation studies and blood counts)
- Chest tube output
| Estimated Enrollment: | 160 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | November 2007 |
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%.
There are currently 96 patients enrolled.
Eligibility| Ages Eligible for Study: | up to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Stephen J. Roth M.D., M.P.H. | Stanford University |
More Information
No publications provided by Stanford University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00779558 History of Changes |
| Other Study ID Numbers: | SU-11132007-879 |
| Study First Received: | October 22, 2008 |
| Last Updated: | October 23, 2008 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Calcium heparin Heparin Anticoagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013