N/A
N=101
Heparin and the Reduction of Thrombosis (HART) Trial
Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT00779558 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Thrombosis — 8; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heparin sulfate infusion at 10 units/kg/hour (Drug); Placebo infusion (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Thrombosis |
8; 6 | — |
| SECONDARY Total PRBCs Transfused |
8.8; 5.6 | — |
| SECONDARY Days to Extubation |
3.5; 3.3 | — |
| SECONDARY Cardiac ICU Length of Stay |
10; 6.9 | — |
| SECONDARY Need for Antibiotics |
14; 9 | — |
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?
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00779558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.