Arista Hemostatic Powder for Total Knee Post Operative Outcomes Study

Overseen By sean mcmillan, DO

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Virtua Health, Inc.

Disqualifiers: Hepatic dysfunction, Renal dysfunction, Cardiac disease, Respiratory disease, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

61 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

How does this treatment differ from other treatments for breast cancer?

This treatment may involve targeting the ARID1A gene, which is a tumor-suppressor gene that, when re-expressed, can inhibit the growth of breast cancer cells. This approach is unique because it focuses on restoring the function of a gene that is often lost in aggressive breast cancer types, potentially offering a new way to slow down or stop tumor progression. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests if using Arista MPH® powder during knee replacement surgery can reduce blood loss and improve recovery. It targets patients with osteoarthritis needing knee surgery. The powder helps blood clot faster, reducing bleeding and aiding healing.

Eligibility Criteria

Inclusion Criteria

Have the mental capacity to provide consent

Are undergoing a primary unilateral total knee arthroplasty

They willingly desire to participate and signed the informed consent

Exclusion Criteria

allergy to Arista MPH®

allergy to tranexamic acid

preoperative hepatic or renal dysfunction

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty with or without Arista hemostatic powder

1 day

1 visit (in-person)

Post-operative Monitoring

Monitoring of hemoglobin, hematocrit, thigh circumference, and knee range of motion

3 months

3 visits (in-person) at 24 hours, 14 days, and 3 months post-op

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Arista

Participant Groups

Group I: Arista group Experimental Treatment 1 Intervention

this group of randomized patients will receive 5 grams of arista hemostatic powder intra-operatively in their wound in addition to 1 gram of IV transexemic acid prior to incision

Group II: control group Active Control 1 Intervention

this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision

Who Is Running the Clinical Trial?

Virtua Health, Inc.

Lead Sponsor

Trials

10

Recruited

690+

Becton, Dickinson and Company

Industry Sponsor

Trials

80

Recruited

92,000+

Tom Polen

Becton, Dickinson and Company

Chief Executive Officer since 2020

Bachelor’s degree from Salisbury University, MBA from Johns Hopkins University

Meera Gopalakrishnan

Becton, Dickinson and Company

Chief Medical Officer

Ph.D. in Biomedical Engineering from the University of Memphis

References

1. England pubmed.ncbi.nlm.nih.gov

An integrated genomic approach identifies ARID1A as a candidate tumor-suppressor gene in breast cancer. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

ADAM12 is A Potential Therapeutic Target Regulated by Hypomethylation in Triple-Negative Breast Cancer. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Loss of ARID1A expression is an early molecular event in tumor progression from ovarian endometriotic cyst to clear cell and endometrioid carcinoma. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Frequent loss of tumor suppressor ARID1A protein expression in adenocarcinomas/adenosquamous carcinomas of the uterine cervix. [2022]

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

Identification of human triple-negative breast cancer subtypes and preclinical models for selection of targeted therapies. [2023]