Hematopoietic Stem Cell Transplant70% EtOHNCT02441075
70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014
A study testing 70% Ethanol in people with Hematopoietic Stem Cell Transplant and GVHD, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This is for a study for patients that will be undergoing hematopoietic stem cell transplant (HSCT). For HSCT, patients will need a double lumen central venous line (CVL). One of the most common complications after an HSCT is Graft Versus Host Disease (GVHD).Tacrolimus or Cyclosporine along with methotrexate are used… Read more about this study
- Who is it for?
- Ages 3 months to 30 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplant, GVHD
- What is being tested?
- 70% Ethanol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jan 2016
- 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 3 months to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients' ages 3 months to 30 years will be eligible for the study.
- All patients undergoing an allogeneic HSCT and receiving intravenous cyclosporine or tacrolimus through a CVL will be eligible.
Who cannot join
- Patients who are hemodynamically compromised or needing intensive care in the ICU.
- Family/patient not willing to sign an informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This is for a study for patients that will be undergoing hematopoietic stem cell transplant (HSCT). For HSCT, patients will need a double lumen central venous line (CVL). One of the most common complications after an HSCT is Graft Versus Host Disease (GVHD).Tacrolimus or Cyclosporine along with methotrexate are used together in order to prevent GVHD. Normally these medications are given via the white lumen and blood is drawn via the unexposed red lumen to check the blood level of these medications. If these drugs are accidentally given via the wrong lumen (line) it could cause blood levels to be falsely high. This error could lead to the patient having to have peripheral blood draws that cause pain. The investigators are proposing adding an ethanol lock to your lumens (lines) to see if this would help clean the lines therefore preventing errors in blood tests and blood draws. An ethanol lock is a 70% alcohol which is injected into the CVL lumen and stays within the CVL as the CVL is capped.
Read the detailed description
As cyclosporine and tacrolimus are both oil based medications and ethanol (70% alcohol) can dissolve oil, the investigators hypothesize that an alcohol lock instilled into the lumen of the CVL will be able to dissolve and leach out the oil based CNI adhering to the inside lumen of the CVL catheter, thus decontaminating it. The safety of using ethanol via CVL is already proven over the last many years. A study performed with neonates resulted in no adverse effects when using ethanol locks, proving that their use is safe for the pediatric population. Ethanol has been used as locks for disinfecting CVLs infected with a broad range of microorganisms in pediatrics. It has also been useful in treating catheter occlusions caused by Lipid formation. By placing a 70% ethanol lock for two hours in the contaminated lumen, it has shown to degrade the biofilm and fat formation allowing for further use of the CVL used 70 % ethanol locks and did not find any reductions in mechanical integrity of polyetherurethane or silicone catheters exposed for as long as 10 weeks. Also, no structural integrity complications have been found in the literature along with no evidence of systemic toxicity with the use of ethanol locks. A retrospective study on PICU patients who had received ethanol locks for 12-24 hours per lumen and a repeat lock when venous access was not limited, flushed 0.2-1mls of ethanol through the catheter at the end of the dwell instead of withdrawing the lock. Sixteen patients who received five daily ethanol lock treatments in succession, had liver enzymes measured and only two patients had mildly elevated transaminases, but these levels were not significant from their baseline levels. There were also no reports from the nurses of any patient complaints or side effects. The study stated that when larger volumes in which they classified as 2.3mls of ethanol are flushed through the central line, patients have reported flushing, light-headedness, headache, nausea and dyspnea. Only 2mls of ethanol will be administered in this study, and the ethanol lock will be withdrawn prior to drawing the levels. Therefore, no side effects are expected.
- Conditions
- Hematopoietic Stem Cell Transplant, GVHD
- Being tested
- 70% Ethanol
- Keywords
- patients, BMT, cyclosporine, tacrolimus, HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
70% EthanolOther
the study will use 70% ethanol lock in the CVLs. A 2ml 70% ethanol lock will be instilled into the white lumen of the CVL for 2 hours. At the end of 2 hours, the ethanol will be withdrawn; the CVL lumen flushed with normal saline, and the CVL would be available for normal use for that day.
| Study group | Role | What they receive |
|---|---|---|
| 70% Ethanol | Experimental | The study will use 70% ethanol lock in the CVLs. A 2ml 70% ethanol lock will be instilled into the white lumen of the CVL for 2 hours. At the end of 2 hours, the ethanol will be withdrawn; the CVL lumen flushed with normal saline, and the CVL would be available for normal use for that day. Receives: Other: 70% Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome: Serum Levels
Serum levels from both lumens will be compared after 2-hour ethanol lock placements. If the mean serum levels drawn at 8pm from both lumens are equivalent, the intervention will be considered effective.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daisy Foundation
- Responsible party
- Principal investigator, Rajinder Bajwa, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441075
- Sponsor's protocol ID
- 14-00028
- Acronym
- 70% EtOH
- Status last verified
- Jan 2016
- First submitted
- 30 Apr 2015
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014
- ClinicalTrials.gov ID
- NCT02441075
- Acronym / sponsor ID
- 70% EtOH / 14-00028
- Conditions
- Hematopoietic Stem Cell Transplant, GVHD
- Keywords
- patients, BMT, cyclosporine, tacrolimus, HSCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Daisy Foundation
- Study start
- May 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 May 2015 (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.
This is for a study for patients that will be undergoing hematopoietic stem cell transplant (HSCT). For HSCT, patients will need a double lumen central venous line (CVL). One of the most common complications after an HSCT is Graft Versus Host Disease (GVHD).Tacrolimus or Cyclosporine along with methotrexate are used together in order to prevent GVHD. Normally these medications are given via the white lumen and blood is drawn via the unexposed red lumen to check the blood level of these medications. If these drugs are accidentally given via the wrong lumen (line) it could cause blood levels to be falsely high. This error could lead to the patient having to have peripheral blood draws that cause pain. The investigators are proposing adding an ethanol lock to your lumens (lines) to see if this would help clean the lines therefore preventing errors in blood tests and blood draws. An ethanol lock is a 70% alcohol which is injected into the CVL lumen and stays within the CVL as the CVL is capped.
Detailed description
As cyclosporine and tacrolimus are both oil based medications and ethanol (70% alcohol) can dissolve oil, the investigators hypothesize that an alcohol lock instilled into the lumen of the CVL will be able to dissolve and leach out the oil based CNI adhering to the inside lumen of the CVL catheter, thus decontaminating it. The safety of using ethanol via CVL is already proven over the last many years. A study performed with neonates resulted in no adverse effects when using ethanol locks, proving that their use is safe for the pediatric population. Ethanol has been used as locks for disinfecting CVLs infected with a broad range of microorganisms in pediatrics. It has also been useful in treating catheter occlusions caused by Lipid formation. By placing a 70% ethanol lock for two hours in the contaminated lumen, it has shown to degrade the biofilm and fat formation allowing for further use of the CVL used 70 % ethanol locks and did not find any reductions in mechanical integrity of polyetherurethane or silicone catheters exposed for as long as 10 weeks. Also, no structural integrity complications have been found in the literature along with no evidence of systemic toxicity with the use of ethanol locks. A retrospective study on PICU patients who had received ethanol locks for 12-24 hours per lumen and a repeat lock when venous access was not limited, flushed 0.2-1mls of ethanol through the catheter at the end of the dwell instead of withdrawing the lock. Sixteen patients who received five daily ethanol lock treatments in succession, had liver enzymes measured and only two patients had mildly elevated transaminases, but these levels were not significant from their baseline levels. There were also no reports from the nurses of any patient complaints or side effects. The study stated that when larger volumes in which they classified as 2.3mls of ethanol are flushed through the central line, patients have reported flushing, light-headedness, headache, nausea and dyspnea. Only 2mls of ethanol will be administered in this study, and the ethanol lock will be withdrawn prior to drawing the levels. Therefore, no side effects are expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 70% Ethanol | Experimental | Other: 70% EthanolThe study will use 70% ethanol lock in the CVLs. A 2ml 70% ethanol lock will be instilled into the white lumen of the CVL for 2 hours. At the end of 2 hours, the ethanol will be withdrawn; the CVL lumen flushed with normal saline, and the CVL would be available for normal use for that day. |
Who may qualify
- Ages
- 3 months to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All patients' ages 3 months to 30 years will be eligible for the study.
- All patients undergoing an allogeneic HSCT and receiving intravenous cyclosporine or tacrolimus through a CVL will be eligible.
Key exclusion criteria (2 listed)
- Patients who are hemodynamically compromised or needing intensive care in the ICU.
- Family/patient not willing to sign an informed consent.
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 |
|---|---|---|
| 70% Ethanolthe study will use 70% ethanol lock in the CVLs. A 2ml 70% ethanol lock will be instilled into the white lumen of the CVL for 2 hours. At the end of 2 hours, the ethanol will be withdrawn; the CVL lumen flushed with normal saline, and the CVL would be available for normal use for that day. | Other | 70% Ethanol |
Primary outcome
Primary Outcome: Serum Levels
Time frame: 18 months
Serum levels from both lumens will be compared after 2-hour ethanol lock placements. If the mean serum levels drawn at 8pm from both lumens are equivalent, the intervention will be considered effective.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 70% Ethanol in people with Hematopoietic Stem Cell Transplant and GVHD, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Outcome: Serum Levels (time frame: 18 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 29 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.