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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

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ClinicalTrials.gov Identifier: NCT00378781
Recruitment Status : Withdrawn (Study withdrawn.)
First Posted : September 21, 2006
Last Update Posted : February 24, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Cancer Drug: Heparin Drug: Minocycline-EDTA Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Genetic and Rare Diseases Information Center resources: Multiple Myeloma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes Ovarian Cancer Ovarian Epithelial Cancer Lymphosarcoma Cutaneous T-cell Lymphoma Follicular Lymphoma Chronic Myeloid Leukemia Primary Myelofibrosis Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Neuroblastoma Soft Tissue Sarcoma B-cell Lymphoma Diffuse Large B-Cell Lymphoma Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Leukemia, T-cell, Chronic Adult T-cell Leukemia/lymphoma Waldenstrom Macroglobulinemia Mycosis Fungoides Osteosarcoma Childhood Acute Lymphoblastic Leukemia Hodgkin Lymphoma Hairy Cell Leukemia Marginal Zone Lymphoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Sezary Syndrome Ewing Sarcoma Chronic Myeloproliferative Disorders Myelodysplastic/myeloproliferative Disease Uterine Sarcoma Leiomyosarcoma Small Intestine Cancer Gestational Trophoblastic Tumor Post-transplant Lymphoproliferative Disease Burkitt Lymphoma Neuroepithelioma Anaplastic Large Cell Lymphoma Chondrosarcoma Wilms' Tumor Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Ovarian Germ Cell Tumor Chronic Neutrophilic Leukemia Aggressive NK Cell Leukemia Lymphomatoid Granulomatosis T-cell Large Granular Lymphocyte Leukemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I
Minocycline hydrochloride + Edetate Calcium Disodium (M-EDTA) flush solution into CVC once daily.
 Drug: Minocycline-EDTA
M-EDTA flush solution into CVC once daily.
Other Names:
  • Minocycline hydrochloride
  • Edetate Calcium Disodium
  • M-EDTA
Experimental: Arm II
Heparin flush solution into CVC once daily.
 Drug: Heparin
Heparin flush solution into CVC once daily.
Other Name: Hep-Lock


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of catheter-related infections during the study period (3 months) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378781


Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jorge Cortes, MD M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00378781    
Other Study ID Numbers: ID93-004
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-ID-93004 ( Other Identifier: UT MD Anderson Cancer Center )
CDR0000500199 ( Registry Identifier: NCI PDQ )
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: February 24, 2012
Last Verified: February 2012
Keywords provided by M.D. Anderson Cancer Center:
infection
poor vascular access
thromboembolism
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia, BCR-ABL negative
blastic phase chronic myelogenous leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
 childhood chronic myelogenous leukemia
chronic eosinophilic leukemia
primary myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
disseminated neuroblastoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
juvenile myelomonocytic leukemia
myelodysplastic/myeloproliferative neoplasm, unclassifiable
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
Additional relevant MeSH terms:
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Infection
Catheter-Related Infections
Minocycline
Heparin
Anticoagulants
 Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents