Heparin or M-EDTA in Preventing Catheter-Related Infections and Blockages in Patients at High Risk for a Catheter-Related Infection - Full Text View

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

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

Resource links provided by NLM:

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000500199, MDA-ID-93004
Study First Received:	September 19, 2006
Last Updated:	November 16, 2008
ClinicalTrials.gov Identifier:	NCT00378781 History of Changes
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
Mantle Cell Lymphoma
Thromboembolism
Fibrin Modulating Agents
Preleukemia
Leukemia, Prolymphocytic
Wilms' Tumor
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Neuroepithelioma
Rhabdomyosarcoma
Anticoagulants
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Testicular Cancer
Leukemia, Myelomonocytic, Chronic

Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Breast Neoplasms
Testicular Neoplasms
Leukemia, Myeloid
Ewing's Sarcoma
Waldenstrom Macroglobulinemia
Leukemia, Myeloid, Accelerated Phase
Uterine Sarcoma
Sarcoma
Flushing
Chronic Myelogenous Leukemia
Lymphoma, Non-Hodgkin
Neoplasms, Glandular and Epithelial
Leiomyosarcoma
Lymphoma, Follicular

Additional relevant MeSH terms:

Anti-Infective Agents
Minocycline
Neuroectodermal Tumors, Primitive
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Neoplasms, Nerve Tissue
Fibrinolytic Agents
Infection
Anti-Bacterial Agents
Fibrin Modulating Agents
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Lymphoma, Large-Cell, Immunoblastic
Lymphoma
Heparin

Anticoagulants
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Agents
Pharmacologic Actions
Lymphatic Diseases
Neuroectodermal Tumors
Neoplasms
Neoplasms, Neuroepithelial
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009