Cancer Clinical Trial
Official title:
Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions
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.
OBJECTIVES:
Primary
- Compare the incidence of catheter-related infections (Staphylococcal and Candida) in
patients at high risk for a catheter-related infection treated with heparin vs
minocycline hydrochloride and edetate calcium disodium (M-EDTA).
Secondary
- Compare the incidence of catheter occlusions in patients treated with these regimens.
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.
- Arm I: Patients receive minocycline hydrochloride and edetate calcium disodium (M-EDTA)
flush solution into the CVC once daily.
- Arm II: Patients receive heparin flush solution into the CVC once daily. Treatment in
both arms continues for up to 3 months in the absence of unacceptable toxicity or until
the removal of the catheter.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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