Heparin or M-EDTA in Preventing Catheter-Related Infections and Blockages in Patients at High Risk for a Catheter-Related Infection
Official Title
Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions
Acronym
Not provided
Organization
M.D. Anderson Cancer CenterOTHER
Status Module
Record Verification Date
Feb 2012
Overall Recruitment Status or Expanded Access Status
Withdrawn
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study withdrawn.
Expanded Access Info
No
Start Date
Not provided
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
Sep 19, 2006
First Submission Date that Met QC Criteria
Sep 19, 2006
First Posted Date
Sep 21, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 22, 2012
Last Update Posted Date
Feb 24, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
M.D. Anderson Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
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.
Conditions Module
Conditions
Cancer
Keywords
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)
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
0Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm I
Experimental
Minocycline hydrochloride + Edetate Calcium Disodium (M-EDTA) flush solution into CVC once daily.
Drug: Minocycline-EDTA
Arm II
Experimental
Heparin flush solution into CVC once daily.
Drug: Heparin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Heparin
Drug
Heparin flush solution into CVC once daily.
Arm II
Hep-Lock
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence of catheter-related infections during the study period (3 months)
3 months
Secondary Outcomes
Measure
Description
Time Frame
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])
3 months
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
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