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

Cancer Clinical Trial

Official title:

Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00378781
• Other study ID #: ID93-004
• Secondary ID: P30CA016672MDA-I
• Status: Withdrawn
• Phase: N/A
• First received: September 19, 2006
• Last updated: February 22, 2012

Study information

• Verified date: February 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Catheter-Related Infections

Intervention

Drug:
• Heparin
Heparin flush solution into CVC once daily.
• Minocycline-EDTA
M-EDTA flush solution into CVC once daily.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of catheter-related infections during the study period (3 months)		3 months	No
Secondary	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	No

External Links

•   UT MD Anderson Cancer Center Website