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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

This study has been withdrawn prior to enrollment.
(Study withdrawn.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00378781
First Posted: September 21, 2006
Last Update Posted: February 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
September 19, 2006
September 21, 2006
February 24, 2012
Not Provided
Not Provided
Incidence of catheter-related infections during the study period (3 months) [ Time Frame: 3 months ]
Not Provided
Complete list of historical versions of study NCT00378781 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
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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
Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Cancer
  • Drug: Heparin
    Heparin flush solution into CVC once daily.
    Other Name: Hep-Lock
  • Drug: Minocycline-EDTA
    M-EDTA flush solution into CVC once daily.
    Other Names:
    • Minocycline hydrochloride
    • Edetate Calcium Disodium
    • M-EDTA
  • Experimental: Arm I
    Minocycline hydrochloride + Edetate Calcium Disodium (M-EDTA) flush solution into CVC once daily.
    Intervention: Drug: Minocycline-EDTA
  • Experimental: Arm II
    Heparin flush solution into CVC once daily.
    Intervention: Drug: Heparin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00378781
ID93-004
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-ID-93004 ( Other Identifier: UT MD Anderson Cancer Center )
CDR0000500199 ( Registry Identifier: NCI PDQ )
No
Not Provided
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Jorge Cortes, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP