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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Status: Withdrawn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

Page last updated: August 23, 2015

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