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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, 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 NLM:

Genetics Home Reference related topics: breast cancer neuroblastoma primary myelofibrosis

MedlinePlus related topics: Acute Lymphocytic Leukemia Acute Myeloid Leukemia Blood Thinners Calcium Cancer Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Fungal Infections Hodgkin Disease Leukemia Lymphoma Melanoma Multiple Myeloma Myelodysplastic Syndromes Neuroblastoma Soft Tissue Sarcoma

Drug Information available for: Edetic acid Edetate sodium Minocycline Minocycline hydrochloride Edetate Calcium Disodium Disodium edetate Calcium gluconate Edetate Disodium Heparin

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Incidence of catheter-related infections during the study period (3 months) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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]) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:

0

Arms	Assigned Interventions
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

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:

UT MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jorge Cortes, M.D., UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00378781 History of Changes
Other Study ID Numbers:	ID93-004, P30CA016672, MDA-ID-93004, CDR0000500199
Study First Received:	September 19, 2006
Last Updated:	August 5, 2010
Health Authority:	United States: Institutional Review Board

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:

Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Immunoblastic
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Catheter-Related Infections
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Infection
Calcium heparin
Edetic Acid
Heparin
Minocycline
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on February 09, 2012