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

Status: Withdrawn

Conditions: Cancer

Treatments: Drug: Heparin; Drug: Minocycline-EDTA

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00378781

P30CA016672 (U.S. NIH Grant/Contract)

MDA-ID-93004 (Other Identifier)

CDR0000500199 (Registry Identifier)

ID93-004

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Arm I

Experimental group

Description:

Minocycline hydrochloride + Edetate Calcium Disodium (M-EDTA) flush solution into CVC once daily.

Treatment:

Drug: Minocycline-EDTA

Arm II

Experimental group

Description:

Heparin flush solution into CVC once daily.

Treatment:

Drug: Heparin