Arista Hemostatic Powder for Blood Loss in Knee Surgery

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Arista hemostatic powder can reduce blood loss, prevent blood clots, and improve movement after knee replacement surgery. Participants will either receive the Arista powder during their surgery or not. The study seeks individuals planning their first knee replacement surgery on one knee. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

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.

What prior data suggests that Arista hemostatic powder is safe for use in surgery?

Research has shown that Arista hemostatic powder is generally safe for use during surgeries. It quickly stops bleeding by forming clots. However, it is not used in surgeries involving the brain, eyes, or urinary system.

Some people have reported minor side effects, including numbness, skin bleeding, infection, fluid buildup under the skin, confusion, and kidney problems. These side effects occur in fewer than 5% of cases.

The product has not been tested on children or pregnant women, so its effects on these groups remain unknown. Overall, Arista is well tolerated in many surgical procedures. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Arista Hemostatic Powder because it offers a novel approach to managing bleeding during knee surgery. Unlike the standard use of intravenous tranexamic acid alone, Arista is applied directly to the surgical wound. This local application potentially enhances clotting right at the site, which could lead to better control of bleeding and improved recovery outcomes. By targeting the wound directly, Arista might reduce the risk of bleeding complications more effectively than current options.

What evidence suggests that Arista hemostatic powder is effective for reducing blood loss in total knee arthroplasty?

Research has shown that Arista hemostatic powder effectively controls bleeding during surgeries. Studies have found that it significantly helps manage blood loss and aids recovery after operations like liver surgery. Arista quickly stops bleeding, potentially leading to better surgical outcomes. This trial will compare two groups: one receiving Arista hemostatic powder with IV tranexamic acid, and the control group receiving only IV tranexamic acid. Although Arista has proven effective in other surgeries, its effects on recovery from knee surgery remain under investigation. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Arista

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10889996/

A Prospective Analysis of the Effects of a Powder-Type ... The results show that Arista® AH significantly improved the perioperative outcomes after liver resection. In particular, the Arista group showed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11127658/

Review of Evidence Supporting the Arista™ Absorbable ... Powder hemostats can be used to control bleeding and are easy to use, have a safe profile, and can achieve broad coverage area at a low cost.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2475037924003637

Comparative analyses of the hemostatic efficacy and ... This study evaluated the hemostatic efficacy of Surgicel (Ethicon), Arista (Becton Dickinson), PerClot (Baxter International) and 4DryField (PlantTec Medical ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf5/P050038b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS The results of this study may not directly correlate with clinical outcomes of use of Arista AH in these applications and clinical outcomes cannot be predicted.

5. researchgate.net researchgate.net/publication/377987666_A_Prospective_Analysis_of_the_Effects_of_a_Powder-Type_Hemostatic_Agent_on_the_Short-Term_Outcomes_after_Liver_Resection

(PDF) A Prospective Analysis of the Effects of a Powder- ... Conclusions: Arista® AH significantly improved intraoperative blood management and postoperative recovery in patients undergoing liver ...

6. bd.com bd.com/en-us/products-and-solutions/products/product-families/arista-ah-absorbable-hemostat

Arista™ AH Absorbable Hemostatic Powder Safety and effectiveness of Arista™ AH have not been clinically evaluated in children and pregnant women. Because there have been reports of decreased amylase ...

7. henryschein.com henryschein.com/assets/Medical/8640026.pdf

Arista™ AH Arista™ AH is an absorbable, plant-based hemostatic powder that accelerates clotting to achieve hemostasis in minutes, using MPH™ technology.

8. bd.com bd.com/content/dam/bd-assets/na/surgery/documents/instructions-for-use/arista-ah-ifu.pdf

arista-ah-ifu.pdf Other adverse events reported in fewer than 5% of the ARISTA™ AH population included: Parethesia, Cutaneous Bleed, Infection, Seroma, Confusion, Renal ...