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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00378781 |
RATIONALE: Heparin or M-EDTA may prevent catheter-related infections and blockages in patients at high risk for a catheter-related infection. It is not yet known whether heparin is more effective than M-EDTA in preventing catheter-related infections and blockages in patients at high risk for a catheter-related infection.
PURPOSE: This randomized clinical trial is studying heparin to see how well it works compared with M-EDTA in preventing catheter-related infections and blockages in patients at high risk for a catheter-related infection.
Condition | Intervention |
Cancer |
Drug: heparin Drug: minocycline-EDTA |
Genetics Home Reference related topics: | breast cancer |
ChemIDplus related topics: | Heparin Minocycline Minocycline hydrochloride |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind |
Official Title: | Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions |
Estimated Enrollment: | 150 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, prospective, multicenter study. Patients are stratified according to type of catheter (tunneled central venous catheter [CVC] vs nontunneled percutaneous CVC) and participating center. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At high risk of acquiring a catheter infection, as evidenced by any of the following:
New (≤ 10 days old) functioning externalized tunneled or nontunneled central venous catheter (CVC), such as a Hickman/Broviac or Hohn catheter, or peripherally inserted central venous catheter (PICC) utilized for infusion of chemotherapy, blood and blood products, or other intermittent infusions
No existing local or systemic catheter infection
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
M.D. Anderson Cancer Center |
National Cancer Institute (NCI) |
Principal Investigator: | Jorge Cortes, MD | M.D. Anderson Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000500199, MDA-ID-93004 |
First Received: | September 19, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00378781 |
Health Authority: | United States: Federal Government |
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