Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378781
Status:
WITHDRAWN
Last Update Posted:
2012-02-24
First Post:
2006-09-19
Brief Title:
Heparin or M-EDTA in Preventing Catheter-Related Infections and Blockages in Patients at High Risk for a Catheter-Related Infection
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Prospective Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions
Status:
WITHDRAWN
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000500199 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-ID-93004 | OTHER | None | None |