Heparin or M-EDTA in Preventing Catheter-Related Infections and Blockages in Patients at High Risk for a Catheter-Related Infection
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: Heparin (Drug); Minocycline-EDTA (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): Jorge Cortes, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center
Summary
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.
Clinical Details
Official title: Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Primary outcome: Incidence of catheter-related infections during the study period (3 months)
Secondary outcome: 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])
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- At high risk of acquiring a catheter infection, as evidenced by any of the following:
- Diagnosis of leukemia, lymphoma, myeloma, or melanoma-sarcoma
- Undergoing hematopoietic stem cell transplantation
- Receiving aldesleukin
- Pediatric cancer patients
- 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 occluded CVC
- No existing local or systemic catheter infection
- More than 3 days since removal of a prior CVC due to an infection
- No externalized CVC that is projected to remain in place for < 2 weeks
- No infusion ports or Groshong catheters
- No coated CVC impregnated with an antimicrobial or antiseptic agent
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 3 months
- No history of allergy to any tetracycline
- No contraindication to flush solution dwell time of ≥ 4 hours
- No hypocalcemia while receiving calcium supplementation through the catheter
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Locations and Contacts
Additional Information
UT MD Anderson Cancer Center Website
Last updated: February 22, 2012
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