Ear nerve (auricular) stimulation to reduce blood loss during dialysis AV graft placement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, sham-controlled, single-center pilot trial enrolls adults undergoing dialysis AV graft placement with a synthetic graft. Participants are randomized 1:1 to receive either 30 minutes of active transcutaneous auricular neurostimulation (tAN) or a sham device immediately before the procedure, in addition to standard surgical care. Blood loss volume and blood-based markers are measured before and during the operation to compare the two groups. The trial aims to determine whether preoperative tAN can lower intraoperative bleeding and related laboratory changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant is undergoing a dialysis port placement procedure using synthetic graft
* Participant is between 18 and 75 years of age
* Participant is English proficient
* Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements

Exclusion Criteria:

* Participant has a BMI ≥ 40
* Participant is currently taking a platelet inhibitor medication
* Participant has a history of epileptic seizures
* Participant has a history of neurological diseases or traumatic brain injury
* Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
* Participant has abnormal ear anatomy or ear infection present
* Person of childbearing age, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
* Person who is pregnant or lactating
* Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Where it's running

• University Surgical Vascular
  Watkinsville, Georgia, United States Recruiting

Study contacts

• Study coordinator: David Sailors, MD
• Email: dsailors@gasurgery.com
• Phone: (706) 549-8306

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.