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

Not Applicable

Withdrawn

• Conditions: Cancer
• Interventions: Drug: Minocycline-EDTA; Drug: Heparin

• Registration Number: NCT00378781
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2006-09-19
• Study First Submitted QC: 2006-09-19
• Study First Posted: 2006-09-21
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-22
• Last Update Posted: 2012-02-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	Minocycline-EDTA	Minocycline hydrochloride + Edetate Calcium Disodium (M-EDTA) flush solution into CVC once daily.
Arm II	Heparin	Heparin flush solution into CVC once daily.

Primary Outcome Measures

Name	Time	Method
Incidence of catheter-related infections during the study period (3 months)	3 months

Secondary Outcome Measures

Name	Time	Method
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