CancerNCT00378781
Heparin or M-EDTA in Preventing Catheter-Related Infections and Blockages in Patients at High Risk for a Catheter-Related Infection
A study testing Heparin and Minocycline-EDTA in people with Cancer, run by M.D. Anderson Cancer Center.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Heparin and Minocycline-EDTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
About this study
Official title: 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.
Read the 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
- Cancer
- Being tested
- Heparin, Minocycline-EDTA
- 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), accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, atypical chronic myeloid leukemia, BCR-ABL negative, blastic phase chronic myelogenous leukemia, childhood acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood chronic myelogenous leukemia, chronic eosinophilic leukemia, primary myelofibrosis, chronic myelomonocytic leukemia, chronic neutrophilic leukemia
- Medical subject headings
- Neoplasms, Infections, Thromboembolism, Congenital Abnormalities, Leukemia, Myeloid, Accelerated Phase, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Blast Crisis, Pdgfra-Associated Chronic Eosinophilic Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
Also called Hep-Lock
Heparin flush solution into CVC once daily.
Minocycline-EDTADrug
Also called Minocycline hydrochloride, Edetate Calcium Disodium, M-EDTA
M-EDTA flush solution into CVC once daily.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Minocycline hydrochloride + Edetate Calcium Disodium (M-EDTA) flush solution into CVC once daily. Receives: Drug: Minocycline-EDTA |
| Arm II | Experimental | Heparin flush solution into CVC once daily. Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter-related infections during the study period (3 months)
Measured: 3 months
Secondary outcomes (1)
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])
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
Why it stopped: Study withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jorge Cortes, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378781
- Sponsor's protocol ID
- ID93-004
- Other IDs
- P30CA016672, MDA-ID-93004, CDR0000500199
- Status last verified
- Feb 2012
- First submitted
- 19 Sep 2006
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions
- ClinicalTrials.gov ID
- NCT00378781
- Acronym / sponsor ID
- ID93-004
- 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)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 21 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Minocycline-EDTAMinocycline hydrochloride + Edetate Calcium Disodium (M-EDTA) flush solution into CVC once daily. |
| Arm II | Experimental | Drug: HeparinHeparin flush solution into CVC once daily. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeparinAlso: Hep-LockHeparin flush solution into CVC once daily. | Drug | Arm II |
| Minocycline-EDTAAlso: Minocycline hydrochloride, Edetate Calcium Disodium, M-EDTAM-EDTA flush solution into CVC once daily. | Drug | Arm I |
Primary outcome
Incidence of catheter-related infections during the study period (3 months)
Time frame: 3 months
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2012.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Cortes, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Heparin and Minocycline-EDTA in people with Cancer, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of catheter-related infections during the study period (3 months) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2012.