70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014
Completed · Not applicable
Conditions studied: Hematopoietic Stem Cell Transplant, GVHD
In brief
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.
Key facts
- Study ID
- NCT02441075
- Run by
- Nationwide Children's Hospital
- People needed
- 13
- Starts
- 2014-05-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2016-01-29
Who can join
Age: 0 and older, up to 30. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients who are hemodynamically compromised or needing intensive care in the ICU.
- Family/patient not willing to sign an informed consent.
Where it is running
- Nationwide Children's Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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