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

ConditionBlood Loss, Surgical

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorUniversity Surgical Vascular

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Volta tAN System
Device
Transcutaneous auricular neurostimulation (tAN)
SHAM Volta tAN System
Device
Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Active tAN + standard of careExperimental treatment 1 intervention

Group B: Sham tAN + standard of careSham comparator 1 intervention

Trial outcomes

Primary outcomes

Mean Total Blood Loss

Comparison of mean total quantified blood loss in active tAN versus sham tAN groups.

Time frame

Throughout procedure

Secondary outcomes

Surgery Time

Surgery time measured as total time from first incision to incision closure in active tAN versus sham tAN groups.

Time frame

First incision to incision closure

Time to Hemostasis

Comparison of mean time to hemostasis in active tAN versus sham tAN groups.

Time frame

From end of AV graft placement to beginning of surgical site closure

Other outcomes

Hemostatic Agent Use

Proportion of participants requiring hemostatic agents

Time frame

During surgery

Duration of time between completing graft placement and application/administration of hemostatic agent

Time frame

During surgery

Proportion of participants achieving hemostasis in <10 minutes

Proportion of participants achieving hemostasis in \<10 minutes

Time frame

During surgery

Blood Assay Results

Blood urea nitrogen (BUN) levels, platelet count, hematocrit, and activated clotting time (ACT)

Time frame

Prior to device placement, during surgery, and at end of surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Surgical Vascular

Lead sponsor

Spark Biomedical, Inc.

Collaborator

Source ClinicalTrials.gov

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