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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Recruitment Status : Withdrawn (Study withdrawn.)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

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 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

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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




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 ]


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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

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00378781     History of Changes
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:
Infection
Catheter-Related Infections
Pharmaceutical Solutions
Calcium heparin
Heparin
Edetic Acid
Minocycline
Pentetic Acid
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Antidotes
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents