Ultrasound for Hemostasis

Overseen By Maaryj Ahmad

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Must not be taking: Anticoagulants, Antiplatelets, Anti-inflammatories, Antihypertensives

Disqualifiers: Obesity, Cancer, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ultrasound on the spleen can affect blood clotting and platelet activity. Researchers are testing three different ultrasound methods to determine the most effective one. Participants will undergo both sham and real ultrasound sessions to compare effects. The study seeks active individuals without significant health issues or recent surgeries who can follow instructions during the trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new medical insights.

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking certain medications at least two weeks before the ultrasound delivery. These include anti-coagulants, anti-platelet agents, anti-inflammatory drugs, anti-hypertensives, and several others that might interfere with the study.

What prior data suggests that this ultrasound technique is safe for hemostasis?

Research shows that using ultrasound, especially at low energy levels, is generally safe. Studies have found that the type of ultrasound used for medical imaging is harmless to humans. The ultrasound in this trial is similar to that used in medical imaging.

In this trial, focused ultrasound can activate certain cells without surgery or injections, making it usually well-tolerated. Previous studies have not identified major safety issues with similar ultrasound methods. However, as this is an early study, some unknowns may still exist.

Even higher-intensity ultrasound has been used safely in medical treatments, such as those for the spleen, without significant problems. This supports the safety of low-energy ultrasound for the spleen.

Overall, current evidence suggests that the ultrasound treatment under study is safe for humans. However, as with any study, discussing potential risks with the research team is important for those considering participation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for ultrasound use in hemostasis because it explores a non-invasive method to manage bleeding. Unlike traditional treatments like surgery or medication, this approach uses low-energy ultrasound waves targeting the spleen to potentially control blood loss. The trial's different techniques—prolonged insonification across the spleen, focused insonification at the center, and prolonged duration at the center—could reveal optimal ways to use ultrasound for effective hemostasis. This could lead to quicker, safer interventions with fewer side effects compared to conventional methods.

What evidence suggests that ultrasound of the spleen utilizing low-energy could be effective for hemostasis?

This trial will compare different ultrasound techniques for spleen-related issues. Research has shown that ultrasound can assist with these conditions. For instance, studies have found that focused ultrasound reduces inflammation by lowering TNF production, a substance involved in inflammation. Evidence also suggests that even low-energy ultrasound can influence spleen function. Additionally, high-intensity ultrasound has successfully stopped spleen bleeding in animals. These findings suggest that ultrasound might enhance platelet function and aid blood clotting, making it a promising option for treating spleen-related conditions. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who can safely undergo ultrasound and are interested in participating in a study that examines the effects of low-energy ultrasound on blood clotting factors. Specific eligibility criteria details were not provided.

Inclusion Criteria

Provision of signed and dated informed consent form

Willingness to comply with all study procedures and availability for the entire study duration

Individuals that are considered English Proficient due to the study requirements to follow verbal commands during the ultrasound session

Exclusion Criteria

Individuals participating in another research study that may affect the conduct or results of this study

Individuals with a substance abuse problem

Individuals with recent alcohol consumption

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 30 minutes of sham stimulation followed by active ultrasound stimulation of the spleen

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in blood biomarkers at several timepoints after stimulation

4 hours

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound of the Spleen Utilizing Low-energy

Trial Overview The trial tests if different ways of applying low-energy ultrasound to the spleen can affect platelet activity and blood coagulation. It's randomized, double-blinded, with three groups receiving varying types and durations of ultrasound.

How Is the Trial Designed?

Group I: Prolonged insonification swept across the spleen Experimental Treatment 1 Intervention

Group II: Prolonged duration Insonification at center of spleen Experimental Treatment 1 Intervention

Group III: Focused insonification at enter of spleen Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

GE Healthcare

Industry Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Published Research Related to This Trial

The survey highlights current opinions on the safety of diagnostic ultrasound applications, indicating a need for ongoing evaluation of its safety profile.

The paper outlines specific labeling requirements for ultrasound equipment as proposed by the Netherlands' Committee on the Safety of Ultrasound, emphasizing the importance of clear communication regarding output levels and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic ultrasound equipment. Safety and dosimetry. Thijssen, JM., van Beekum, WT., Daniëls, O., et al.[2005]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10330863/

Focused ultrasound neuromodulation of the spleen ... These findings demonstrate the ultrasound energy can be precisely targeted to the spleen to activate anti-inflammatory effects in humans. 2. Methods. 2.1.

2. withpower.com withpower.com/trial/ultrasound-for-hemostasis-00177

Ultrasound for Hemostasis · Info for Participants This suggests that using ultrasound, even at low energy, can be effective in managing spleen-related conditions. Show more ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12478037/

Spleen hemostasis using high-intensity ultrasound - PubMed Results: All 14 splenic injuries were hemostatic after an average of 96 seconds of HIFU application. There was evidence of rebleeding in one animal between days ...

4. researchgate.net researchgate.net/publication/232206489_Spleen_Hemostasis_Using_High-Intensity_Ultrasound_Survival_and_Healing

Spleen Hemostasis Using High-Intensity Ultrasound Results : All 14 splenic injuries were hemostatic after an average of 96 seconds of HIFU application. There was evidence of rebleeding in one ...

5. nature.com nature.com/articles/s41467-019-08750-9

Noninvasive sub-organ ultrasound stimulation for targeted ... We demonstrate a noninvasive method to modulate specific signaling pathways within organs using ultrasound (U/S).

6. trial.medpath.com trial.medpath.com/clinical-trial/c3c50a06c5cb4686/nct06934096-ultrasound-spleen-platelet-coagulation

Ultrasound of the Spleen Utilizing Low-energy (Diagnostic ... The primary objective is to determine whether diagnostic-level ultrasound to the spleen can modulate systemic blood biomarkers of hemostasis. Secondary Outcome ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4207154/

High-intensity focused ultrasound ablation: an effective and ... The conventional treatment is splenectomy and partial splenic embolization; however, both of them have high complication rates and technical defects. Therefore, ...