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

Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures

This trial will try a noninvasive ear (auricular) vagus nerve stimulation device to see if it reduces blood loss in adults having dialysis AV graft placement.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University Surgical Vascular (industry)
• Locations: 1 site (Watkinsville, Georgia)
• Trial ID: NCT06647017 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 who are English proficient, able to give informed consent, and scheduled for dialysis AV graft (synthetic) placement are ideal candidates.

Not a fit: Patients with BMI ≥40, on platelet inhibitor medications, with a history of seizures or neurological disease, implanted electronic devices (e.g., pacemaker), abnormal ear anatomy or ear infection, pregnant or lactating people, or other significant comorbidities are unlikely to receive benefit or are excluded.

Why it matters

Potential benefit: If successful, the device could reduce intraoperative blood loss during AV graft placement, potentially lowering the need for transfusion and reducing surgical complications.

How similar studies have performed: Vagus nerve and transcutaneous auricular stimulation have shown effects in pain, inflammation, and other conditions, but applying tAN specifically to reduce surgical blood loss is novel with only limited preliminary support.

Eligibility criteria

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 this trial is running

Watkinsville, Georgia

• University Surgical Vascular — Watkinsville, Georgia, United States (RECRUITING)

Study contacts

• Study coordinator: David Sailors, MD

Conditions: Blood Loss, Surgical, auricular neurostimulation, vagus nerve stimulation, transcutaneous, blood loss, transcutaneous auricular neurostimulation, tAN