Heparin and the Reduction of Thrombosis (HART) Trial

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779558
• Other study ID #: SU-11132007-879
• Status: Completed
• Phase: N/A
• First received: October 22, 2008
• Last updated: June 10, 2015
• Start date: November 2005
• Est. completion date: November 2007

Study information

• Verified date: June 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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?

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• Heparin sulfate infusion at 10 units/kg/hour
Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery
• Placebo infusion
Infusion of normal saline

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Total PRBCs Transfused		While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)	Yes
Secondary	Days to Extubation		While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)	No
Secondary	Cardiac ICU Length of Stay		While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)	No
Secondary	Need for Antibiotics		While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)	No