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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 completed.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00378781
  Purpose

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 Intervention
Cancer
Drug: heparin
Drug: minocycline-EDTA

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Fungal Infections    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Melanoma    Multiple Myeloma    Soft Tissue Sarcoma   

ChemIDplus related topics:   Heparin    Minocycline    Minocycline hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Double-Blind
Official Title:   Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Incidence of catheter-related infections during the study period (3 months)

Secondary Outcome Measures:
  • 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])

Estimated Enrollment:   150
Primary Completion Date:   December 2007 (Final data collection date for primary outcome measure)

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
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378781

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Jorge Cortes, MD     M.D. Anderson Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000500199, MDA-ID-93004
First Received:   September 19, 2006
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00378781
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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  
blastic phase chronic myelogenous leukemia  
childhood acute lymphoblastic leukemia in remission  
childhood acute myeloid leukemia in remission  
childhood chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic 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 disease, 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

Study placed in the following topic categories:
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Malignant mesenchymal tumor
Lymphoma, small cleaved-cell, diffuse
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Thromboembolism
Lymphomatoid granulomatosis
Ewing's sarcoma
Preleukemia
Leukemia, Prolymphocytic
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Neuroepithelioma
Rhabdomyosarcoma
Myelodysplastic syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Acute myelogenous leukemia
Breast Neoplasms
Testicular Neoplasms
Leukemia, Myeloid
Waldenstrom Macroglobulinemia
Leukemia, Myeloid, Accelerated Phase
B-cell lymphomas
Sarcoma
Flushing

Additional relevant MeSH terms:
Anti-Infective Agents
Anticoagulants
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Neoplasms, Nerve Tissue
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Infection
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Fibrin Modulating Agents
Therapeutic Uses
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on October 17, 2008




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