Clinical trial NCT06647017: Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
Official title: Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Blood Loss, Surgical
Keywords: auricular neurostimulation
vagus nerve stimulation
transcutaneous
blood loss
transcutaneous auricular neurostimulation
tAN
Lead sponsor: University Surgical Vascular
Sponsor class: INDUSTRY
Collaborators: name: Spark Biomedical, Inc.
First posted: 2024-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Total Blood Loss
timeFrame: Throughout procedure
Secondary outcomes:
measure: Surgery Time
timeFrame: First incision to incision closure
measure: Time to Hemostasis
timeFrame: From end of AV graft placement to beginning of surgical site closure
Other outcomes:
measure: Hemostatic Agent Use
timeFrame: During surgery
measure: Duration of time between completing graft placement and application/administration of hemostatic agent
timeFrame: During surgery
measure: Proportion of participants achieving hemostasis in <10 minutes
timeFrame: During surgery
measure: Blood Assay Results
timeFrame: Prior to device placement, during surgery, and at end of surgery
measure: Treatment-Related Adverse Events (Safety)
timeFrame: Thorough study completion, an average of 4 hours
Locations:
city: Watkinsville
country: United States
facility: University Surgical Vascular
state: Georgia
Study officials:
References: