Heparin and the Reduction of Thrombosis (HART) Trial

NCT00779558 | Completed Results

• 1 other identifier: SU-11132007-879
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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?

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

Study Arms (2)

Study drug

ACTIVE COMPARATOR

Heparin sulfate infusion at 10 units/kg/hour

Drug: Heparin sulfate infusion at 10 units/kg/hour

Placebo

PLACEBO COMPARATOR

Placebo - normal saline infusion

Drug: Placebo infusion

Interventions

Heparin sulfate infusion at 10 units/kg/hour DRUG

Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery

Also known as: heparin

Study drug

Placebo infusion DRUG

Infusion of normal saline

Placebo

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All infants \< 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital \& #xA

You may not qualify if:

• Known coagulopathy
• History of clinically significant bleeding (GI, cranial, pulmonary)
• Need for therapeutic heparinization
• ECMO

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Schroeder AR, Axelrod DM, Silverman NH, Rubesova E, Merkel E, Roth SJ. A continuous heparin infusion does not prevent catheter-related thrombosis in infants after cardiac surgery. Pediatr Crit Care Med. 2010 Jul;11(4):489-95. doi: 10.1097/PCC.0b013e3181ce6e29.

  PMID: 20101197 DERIVED

MeSH Terms

Conditions

Thrombosis

Interventions

Heparin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Alan Schroeder
• Organization: Stanford University

alan.schroeder@hhs.sccgov.org

408 885-5260

Study Officials

• Stephen J. Roth M.D., M.P.H.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 24, 2008
• Study Start: November 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: June 12, 2015
• Results First Posted: June 12, 2015

Record last verified: 2015-06

Locations

US (1)