← Back to Search

Behavioural Intervention

Neurostimulation Therapy for Reducing Blood Loss

N/A

Waitlist Available

Research Sponsored by University Surgical Vascular

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is undergoing a dialysis port placement procedure using synthetic graft

Participant is between 18 and 75 years of age

Must not have

Participant has a BMI ≥ 40

Participant is currently taking a platelet inhibitor medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up thorough study completion, an average of 4 hours

Summary

This trial aims to find out if a specific therapy called tAN therapy can help reduce the amount of blood lost during dialysis AV graft placement procedures.

Who is the study for?

This trial is for individuals undergoing dialysis AV graft placement procedures. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and not have conditions that could interfere with the study or increase risk.

What is being tested?

The study is testing whether tAN therapy using the Volta tAN System can reduce blood loss during AV graft placement compared to a SHAM (placebo-like) device. Participants will be randomly assigned to receive either the actual tAN therapy or a non-functional sham treatment.

What are the potential side effects?

Potential side effects are not detailed in the information provided. However, as this involves transcutaneous neurostimulation, possible side effects might include skin irritation at the site of application, discomfort from stimulation, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am getting a dialysis port with a synthetic graft.

Select...

I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My BMI is 40 or higher.

Select...

I am currently on medication to prevent blood clots.

Select...

I have a history of neurological diseases or brain injury.

Select...

I have an ear infection or my ear shape is unusual.

Select...

I have a history of epileptic seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and during surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Total Blood Loss

Secondary study objectives

Surgery Time

Time to Hemostasis

Other study objectives

Blood Assay Results

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

Hemostatic Agent Use

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tAN + standard of careExperimental Treatment1 Intervention

Participants randomized to the active group will have an earpiece applied and receive 30 minutes of active tAN therapy immediately prior to the dialysis port placement procedure. When the 30-minute tAN session is complete, the system will be turned off, unplugged, and the earpiece will be removed.

Group II: Sham tAN + standard of carePlacebo Group1 Intervention

Participants randomized to the sham group will have an earpiece applied, but stimulation will not be turned on. These participants will receive 30 minutes of sham tAN therapy immediately prior to the dialysis port placement procedure. When the 30-minute tAN session is complete, the system will be turned off, unplugged, and the earpiece will be removed.

0 / 7Eligibility criteria met