Phase 1 N=61 Randomized Single-blind Prevention

Arista Hemostatic Powder for Total Knee Post Operative Outcomes Study

Blood Loss, Surgical

Bottom Line

View on ClinicalTrials.gov: NCT05522153 ↗

Enrolled (actual)

Serious AEs

8.5%

Results posted

Sep 2024

Primary outcome: Primary: Blood Loss — 122.6; 133.3 cubic centimeters

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Arista (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Virtua Health, Inc.
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Blood Loss	122.6; 133.3	—
SECONDARY Thigh Circumference	50.6; 54	—
SECONDARY Range of Motion	117.8; 114.3	—

Summary

To examine in Arista hemostatic powder results in less post-total knee arthroplasty blood loss, hematoma formation, and improved range of motion when compared to patients who did not receive the product.

Eligibility Criteria

Inclusion Criteria

• They willingly desire to participate and signed the informed consent
Are between the ages of 18 and 100 years of age
Have the mental capacity to provide consent
Are undergoing a primary unilateral total knee arthroplasty

Exclusion Criteria

• allergy to Arista MPH®
allergy to tranexamic acid
preoperative hepatic or renal dysfunction
serious cardiac or respiratory disease including coronary artery stent placement
congenital or acquired coagulopathy as evidence by INR > 1.4 or PTT > 1.4 times normal
thrombocytopenia as identified by a preoperative platelet count of < 150,000/mm3
history of thromboembolic disease
pregnant or breast feeding
donated preoperative autologous blood
diagnosis of inflammatory arthritis
a preoperative hemoglobin < 10 g/dL.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05522153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.