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

39 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Ultrasound of the Spleen Utilizing Low-energy for hemostasis?

Research shows that contrast-enhanced ultrasound (CEUS) improves the accuracy of detecting and managing splenic injuries, making it a reliable alternative to traditional ultrasound for low-grade abdominal trauma. This suggests that using ultrasound, even at low energy, can be effective in managing spleen-related conditions. ^{1 2 3 4 5}

Is ultrasound for hemostasis safe for humans?

The safety of diagnostic ultrasound, including its use for hemostasis, is generally supported by existing opinions and data on output levels, as described in a survey by the Netherlands' Committee on the Safety of Ultrasound. ^{1 2 3 6 7}

How does the ultrasound treatment for hemostasis differ from other treatments?

The ultrasound treatment for hemostasis, specifically using high-intensity focused ultrasound (HIFU), is unique because it uses sound waves to stop bleeding by heating tissues and causing them to clot quickly. This method is non-invasive and can rapidly achieve hemostasis in seconds, unlike traditional surgical methods that may take longer and involve more physical intervention. ^{8 9 10 11 12}

What is the purpose of this trial?

This is a three-cohort, randomized, double-blinded , sham-controlled, single-center, early feasibility research trial to determine whether organ-specific biologic effects on platelet activity and coagulation are achievable through selective ultrasound of the spleen utilizing low-energy (diagnostic-level) insonification. * Group 1: Focused insonification at center of the spleen. * Group 2: Prolonged duration insonification at center of the spleen * Group 3: Prolonged duration insonification across the spleen. Participants will receive 30 minutes of sham stimulation in the randomized group that is assigned to them, followed by active stimulation within the same group. Blood biomarkers (local and systemic) will be measured before and at several timepoints after stimulation to measure the molecular and cellular effects of the device

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. Romania pubmed.ncbi.nlm.nih.gov

Contrast-enhanced ultrasound performance in predicting blunt splenic injuries requiring only observation and monitoring. [2019]

2. China pubmed.ncbi.nlm.nih.gov

[Role of contrast-enhanced ultrasound in management of splenic trauma]. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Microwave coagulation therapy and drug injection to treat splenic injury. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Role of contrast-enhanced ultrasound (CEUS) in the diagnosis and management of traumatic splenic injuries. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Spleen hemostasis using high-intensity ultrasound: survival and healing. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

Diagnostic ultrasound equipment. Safety and dosimetry. [2005]

7. England pubmed.ncbi.nlm.nih.gov

Shared drink and a soft punch: an almost deadly combination. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Focal lesions in the ultrasonographic examination of the spleen as a symptom of various disease statuses: literature survey and case descriptions. [2016]

9. Germany pubmed.ncbi.nlm.nih.gov

[Ultrasound diagnostics of renal blood vessels and transplant kidney]. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

High intensity focused ultrasound: a method of hemostasis. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Hemostasis of punctured vessels using Doppler-guided high-intensity ultrasound. [2019]

12. Poland pubmed.ncbi.nlm.nih.gov

Standards of the Polish Ultrasound Society - update. Spleen examination. [2020]