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

Not Applicable

Not yet recruiting

• Conditions: Blood Loss, Surgical

• Registration Number: NCT06647017
• Lead Sponsor: University Surgical Vascular

Brief Summary

The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.

Detailed Description

This study is designed as a randomized, double-blind, sham-controlled, single-center, pilot clinical trial in which adults undergoing dialysis port placement procedures will be randomized 1:1 into one of two treatment groups:

Group 1: Active tAN + standard of care Group 2: Sham tAN + standard of care

Participants will receive 30 minutes of active or sham tAN immediately prior to the dialysis port placement procedure. Blood loss and blood markers will be measured before and during the procedure to measure the effect of the therapy.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-17
• Study Start: 2024-11-01
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Total Blood Loss	Throughout procedure	Comparison of mean total quantified blood loss in active tAN versus sham tAN groups.

Secondary Outcome Measures

Name	Time	Method
Surgery Time	First incision to incision closure	Surgery time measured as total time from first incision to incision closure in active tAN versus sham tAN groups.
Time to Hemostasis	From end of AV graft placement to beginning of surgical site closure	Comparison of mean time to hemostasis in active tAN versus sham tAN groups.

Trial Locations

Locations (1)

University Surgical Vascular; 🇺🇸 Watkinsville, Georgia, United States