- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00378781
Heparin or M-EDTA in Preventing Catheter-Related Infections and Blockages in Patients at High Risk for a Catheter-Related Infection
Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions
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.
Study Overview
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 Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Minocycline hydrochloride + Edetate Calcium Disodium (M-EDTA) flush solution into CVC once daily.
|
M-EDTA flush solution into CVC once daily.
Other Names:
|
Experimental: Arm II
Heparin flush solution into CVC once daily.
|
Heparin flush solution into CVC once daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of catheter-related infections during the study period (3 months)
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
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])
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified childhood solid tumor, protocol specific
- stage III malignant testicular germ cell tumor
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- unspecified adult solid tumor, protocol specific
- primary myelofibrosis
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage I mycosis fungoides/Sezary syndrome
- stage I chronic lymphocytic leukemia
- thromboembolism
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- recurrent ovarian epithelial cancer
- infection
- stage IIIC breast cancer
- chondrosarcoma
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- stage III childhood small noncleaved cell lymphoma
- stage IV childhood small noncleaved cell lymphoma
- stage IV childhood large cell lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- recurrent melanoma
- stage IV melanoma
- chronic myelomonocytic leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- 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)
- secondary acute myeloid leukemia
- childhood acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- juvenile myelomonocytic leukemia
- chronic phase chronic myelogenous leukemia
- childhood chronic myelogenous leukemia
- childhood myelodysplastic syndromes
- recurrent adult acute myeloid leukemia
- adult acute myeloid leukemia in remission
- recurrent adult Hodgkin lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- Waldenstrom macroglobulinemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage II multiple myeloma
- stage III multiple myeloma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- recurrent small intestine cancer
- stage I multiple myeloma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- primary central nervous system non-Hodgkin lymphoma
- refractory chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- localized osteosarcoma
- previously treated childhood rhabdomyosarcoma
- recurrent childhood rhabdomyosarcoma
- stage III melanoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- intraocular lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- adult grade III lymphomatoid granulomatosis
- recurrent adult grade III lymphomatoid granulomatosis
- post-transplant lymphoproliferative disorder
- disseminated neuroblastoma
- recurrent neuroblastoma
- refractory multiple myeloma
- recurrent adult acute lymphoblastic leukemia
- refractory hairy cell leukemia
- prolymphocytic leukemia
- stage IV adult soft tissue sarcoma
- recurrent adult soft tissue sarcoma
- small intestine leiomyosarcoma
- stage IV uterine sarcoma
- recurrent uterine sarcoma
- recurrent childhood acute lymphoblastic leukemia
- stage I childhood large cell lymphoma
- stage II childhood large cell lymphoma
- stage III childhood large cell lymphoma
- stage I childhood lymphoblastic lymphoma
- stage II childhood lymphoblastic lymphoma
- stage III childhood lymphoblastic lymphoma
- stage IV childhood lymphoblastic lymphoma
- stage I childhood small noncleaved cell lymphoma
- stage II childhood small noncleaved cell lymphoma
- stage II ovarian epithelial cancer
- stage II melanoma
- contiguous stage II mantle cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- stage I uterine sarcoma
- stage II uterine sarcoma
- stage III uterine sarcoma
- recurrent ovarian germ cell tumor
- stage IV childhood Hodgkin lymphoma
- recurrent childhood acute myeloid leukemia
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- atypical chronic myeloid leukemia, BCR-ABL negative
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- recurrent childhood lymphoblastic lymphoma
- stage III childhood Hodgkin lymphoma
- recurrent malignant testicular germ cell tumor
- metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
- recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
- metastatic osteosarcoma
- recurrent osteosarcoma
- stage III adult soft tissue sarcoma
- stage I mantle cell lymphoma
- acute undifferentiated leukemia
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage I adult Burkitt lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I childhood Hodgkin lymphoma
- stage II childhood Hodgkin lymphoma
- stage I melanoma
- stage II adult soft tissue sarcoma
- recurrent Wilms tumor and other childhood kidney tumors
- meningeal chronic myelogenous leukemia
- poor prognosis metastatic gestational trophoblastic tumor
- childhood grade III lymphomatoid granulomatosis
- recurrent childhood grade III lymphomatoid granulomatosis
- metastatic childhood soft tissue sarcoma
- recurrent childhood soft tissue sarcoma
- contiguous stage II grade 3 follicular lymphoma
- stage I grade 3 follicular lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage II mycosis fungoides/Sezary syndrome
- mast cell leukemia
- stage I adult T-cell leukemia/lymphoma
- stage II adult T-cell leukemia/lymphoma
- T-cell large granular lymphocyte leukemia
- contiguous stage II adult lymphoblastic lymphoma
- stage I adult lymphoblastic lymphoma
- stage I adult soft tissue sarcoma
- previously untreated childhood rhabdomyosarcoma
- nonmetastatic childhood soft tissue sarcoma
- localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
- poor vascular access
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID93-004
- P30CA016672 (U.S. NIH Grant/Contract)
- MDA-ID-93004 (Other Identifier: UT MD Anderson Cancer Center)
- CDR0000500199 (Registry Identifier: NCI PDQ)
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