Full Text View
Tabular View
No Study Results Posted
Related Studies
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 completed.
Study NCT00378781   Information provided by National Cancer Institute (NCI)
First Received: September 19, 2006   Last Updated: November 16, 2008   History of Changes

September 19, 2006
November 16, 2008
 
December 2007   (final data collection date for primary outcome measure)
Incidence of catheter-related infections during the study period (3 months)
Same as current
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])
Same as current
 
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
Supportive Care, Randomized, Double-Blind
Cancer
  • Drug: heparin
  • Drug: minocycline-EDTA
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
150
 
December 2007   (final data collection date for primary outcome measure)

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00378781
 
CDR0000500199, MDA-ID-93004
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Jorge Cortes, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
September 2007

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