Arista Hemostatic Powder for Total Knee Post Operative Outcomes Study

NCT05522153 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: virtuamcmillan1
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Loss, Surgical

Outcome Measures

Primary Outcomes (1)

• Blood Loss

  Calculated on standard hospital protocol

  Time of incision until 90 days post-op

Secondary Outcomes (2)

• Thigh Circumference

  3 months post op

• Range of Motion

  3 months post op

Study Arms (2)

Arista group

EXPERIMENTAL

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

Drug: Arista

control group

NO INTERVENTION

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

Interventions

Arista DRUG

hemostatic powder

Arista group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virtua Health, Inc.: lead
• Becton, Dickinson and Company: collaborator

Study Sites (1)

Virtua Health System

Marlton, New Jersey, 08053-9697, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Arista

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Results Point of Contact

• Title: Sean McMillan
• Organization: Virtua Medical Group, PA

smcmillan@virtua.org

908-812-7542

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients are blinded as to their randomization group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled study

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: August 30, 2022
• Study Start: May 1, 2021
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)