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Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer

NCT00633061 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2020-10-08

Study results available
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Summary

The primary hypothesis of this study is that occult catheter-related DVT in children with cancer is common and directly contributes to development of serious catheter complications, specifically bacteremia/fungemia and/or recurrent occlusion of the catheter tip. Accordingly, anticoagulant treatment of clinically silent (occult) DVT will reduce rates of catheter-related infection and occlusion, delays in therapy and need for catheter replacement.

Conditions

  • Childhood Cancer
  • Central Venous Catheters
  • Deep Vein Thrombosis
  • Catheter-related Infection
  • Catheter-related Occlusion

Interventions

DRUG

Enoxaparin

Lovenox ® is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. It is given as a subcutaneous injection twice daily. Dose of enoxaparin (Lovenox ®) will be 1 mg/kg every 12 hours for children \>2 months and 1.5 mg/kg every 12 hours for infants \<2 months. Duration of treatment is 6 weeks.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Janna Journeycake, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-06-30
Completion
2011-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00633061 on ClinicalTrials.gov