Heparin or M-EDTA in Preventing Catheter-Related Infections and Blockages in Patients at High Risk for a Catheter-Related Infection

M.D. Anderson Cancer Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Conditions

Cancer

Interventions

HeparinDRUG

Heparin flush solution into CVC once daily.

Minocycline-EDTADRUG

M-EDTA flush solution into CVC once daily.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of catheter-related infections during the study period (3 months)

Time frame: 3 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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