Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Completed	Any age	NCI	MDA-ID-93004 MDA ID93-004, NCT00378781

Objectives

Primary

1. 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

1. Compare the incidence of catheter occlusions in patients treated with these regimens.

Entry 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

Prior/Concurrent Therapy:

• See Disease Characteristics

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

Expected Enrollment

A total of 150 patients will be accrued for this study.

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Jorge Cortes, MD, Principal investigator		Ph: 713-794-5783; 800-392-1611 Email: jcortes@mdanderson.org

Registry Information
Official Title		Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions
Trial Completion Date		2007-12-28
Registered in ClinicalTrials.gov		NCT00378781
Date Submitted to PDQ		2006-07-31
Information Last Verified		2007-09-30
NCI Grant/Contract Number		CA16672

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