An interventional study of Heparin and Minocycline-EDTA in Cancer, sponsored by M.D. Anderson Cancer Center. Withdrawn. Per ClinicalTrials.gov, last updated 2012-02-24.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Supportive care
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
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.
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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:
Minocycline hydrochloride + Edetate Calcium Disodium (M-EDTA) flush solution into CVC once daily.
Drug: Minocycline-EDTA
Heparin flush solution into CVC once daily.
Drug: Heparin
Heparin flush solution into CVC once daily.
Also known as: Hep-Lock
M-EDTA flush solution into CVC once daily.
Also known as: Minocycline hydrochloride, Edetate Calcium Disodium, M-EDTA
Incidence of catheter-related infections during the study period (3 months)
Time frame: 3 months
Incidence of catheter occlusions during periods of prophylaxis (e.g., time period in which the catheter is locked with heparin or minocycline hydrochloride and edetate calcium disodium [M-EDTA])
Time frame: 3 months
No study locations are listed for this record.
This study is withdrawn, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center