Blood Loss, SurgicalPhase 1NCT05522153
Arista Hemostatic Powder for Total Knee Post Operative Outcomes Study
A Phase 1 study testing Arista in people with Blood Loss, Surgical, run by Virtua Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Arista
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 8 Jun 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
Show all 11Show fewer
- history of thromboembolic disease
- pregnant or breast feeding
- donated preoperative autologous blood
- diagnosis of inflammatory arthritis
- a preoperative hemoglobin < 10 g/dL.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virtua Health System
Marlton, New Jersey, 08053-9697
About this study
Official title: A Single Blinded Randomized Control Trial Comparing the Use of ARISTA Polysaccharide Hemostat in Total Knee Arthroplasty (TKA)
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.
Read the detailed description
Patients will be recruited from the Hospital for Special Surgery and Our Lady of Lourdes Programs. Patients will be prospectively enrolled when Institutional Review Board (IRB) approval is obtained. All patients will be undergoing a primary unilateral total knee arthroplasty for a diagnosis of osteoarthritis. Once enrolled in the study, each patient will be randomized into one of two groups. Group A will undergo a TKA utilizing Arista MPH ® intra-operatively. Group B will undergo a TKA without Arista MPH ®. All patients will receive a baseline IV dose of tranexamic acid per weight based guidelines prior to incision.
A thigh tourniquet will be utilized from prior to incision until wound closure is complete. Arista MPH ® will be used intra-operatively. A 5 gram vial of Arista MPH will be the standard of use. ARISTA will be used in accordance with the instructions for use. Additional need for Arista MPH ® usage during the case will be permitted and recorded. Standard electrocautory will be permitted, however additional thermal devices intended for hemostatic control will not be utilized.
Pre-operative hemoglobin, hematocrit, PT, PTT, and INR will be per standard institutional protocol within 30 days of surgery. The hemoglobin and hematocrit will be repeated 24 hours after the procedure per standard physician protocol. IV fluids administered pre-op, intra-op and post op for the first 24 hours will be recorded. Administration of any blood products from the time of incision until 90 days post-op will be recorded. Blood loss will be calculated via standard HSS. Drains will not be utilized.
The transfusion criteria is: a hemoglobin level of <8 g/dL or a hemoglobin level of <10 g/dL in a patient with symptomatic anemia or deemed at high risk because of notable underlying cardiac comorbidities. Blood will be administered 1 unit at a time, and the presence of symptoms or signs was reassessed.
Pre-operative thigh circumference will be measured on the day of the surgery. For standardization, the circumference will be recorded 15 cm proximal to the superior pole of the patella. Post-operatively the thigh circumference will be measured at 24 hours, post-operative day 14 +/- 4 days, and post operatively at 3 months +/- 1 week.
Post-operative knee range of motion will be recorded at 24 hours, post-operative day 14 +/- 4 days, and post-operatively at 3 months +/- 1 week.
Pre-operative and post-operative day 14 (+/- 4 days) and post-operative 3 months (+/- 1 week) knee society short form scores will be collected All post-operative adverse events related to the procedure will be recorded. These invents include, but are not limited to: readmission, infection, prosthesis loosening, wound dehiscence, and wound drainage.
All data will be de-identified and securely maintained in an IRB approved manner.
- Conditions
- Blood Loss, Surgical
- Being tested
- Arista
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AristaDrug
hemostatic powder
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Arista |
| control group | No intervention | this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Loss
Calculated on standard hospital protocol
Measured: Time of incision until 90 days post-op
Secondary outcomes (2)
Thigh Circumference
Thigh circumference measurement 15 cm above the top of the patella
Measured: 3 months post op
Range of Motion
Measured in degrees
Measured: 3 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 May 2021
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virtua Health, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522153
- Sponsor's protocol ID
- virtuamcmillan1
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2022
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blinded Randomized Control Trial Comparing the Use of ARISTA Polysaccharide Hemostat in Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT05522153
- Acronym / sponsor ID
- virtuamcmillan1
- Conditions
- Blood Loss, Surgical
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Virtua Health, Inc.University, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Study start
- 1 May 2021 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be recruited from the Hospital for Special Surgery and Our Lady of Lourdes Programs. Patients will be prospectively enrolled when Institutional Review Board (IRB) approval is obtained. All patients will be undergoing a primary unilateral total knee arthroplasty for a diagnosis of osteoarthritis. Once enrolled in the study, each patient will be randomized into one of two groups. Group A will undergo a TKA utilizing Arista MPH ® intra-operatively. Group B will undergo a TKA without Arista MPH ®. All patients will receive a baseline IV dose of tranexamic acid per weight based guidelines prior to incision.
A thigh tourniquet will be utilized from prior to incision until wound closure is complete. Arista MPH ® will be used intra-operatively. A 5 gram vial of Arista MPH will be the standard of use. ARISTA will be used in accordance with the instructions for use. Additional need for Arista MPH ® usage during the case will be permitted and recorded. Standard electrocautory will be permitted, however additional thermal devices intended for hemostatic control will not be utilized.
Pre-operative hemoglobin, hematocrit, PT, PTT, and INR will be per standard institutional protocol within 30 days of surgery. The hemoglobin and hematocrit will be repeated 24 hours after the procedure per standard physician protocol. IV fluids administered pre-op, intra-op and post op for the first 24 hours will be recorded. Administration of any blood products from the time of incision until 90 days post-op will be recorded. Blood loss will be calculated via standard HSS. Drains will not be utilized.
The transfusion criteria is: a hemoglobin level of <8 g/dL or a hemoglobin level of <10 g/dL in a patient with symptomatic anemia or deemed at high risk because of notable underlying cardiac comorbidities. Blood will be administered 1 unit at a time, and the presence of symptoms or signs was reassessed.
Pre-operative thigh circumference will be measured on the day of the surgery. For standardization, the circumference will be recorded 15 cm proximal to the superior pole of the patella. Post-operatively the thigh circumference will be measured at 24 hours, post-operative day 14 +/- 4 days, and post operatively at 3 months +/- 1 week.
Post-operative knee range of motion will be recorded at 24 hours, post-operative day 14 +/- 4 days, and post-operatively at 3 months +/- 1 week.
Pre-operative and post-operative day 14 (+/- 4 days) and post-operative 3 months (+/- 1 week) knee society short form scores will be collected All post-operative adverse events related to the procedure will be recorded. These invents include, but are not limited to: readmission, infection, prosthesis loosening, wound dehiscence, and wound drainage.
All data will be de-identified and securely maintained in an IRB approved manner.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Arista group | Experimental | Drug: Aristathis 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 |
| control group | No intervention | –this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • They willingly desire to participate and signed the informed consent
Key exclusion criteria (11 listed)
- • allergy to Arista MPH®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aristahemostatic powder | Drug | Arista group |
Primary outcome
Blood Loss
Time frame: Time of incision until 90 days post-op
Calculated on standard hospital protocol
2 secondary outcomes
Thigh Circumference
Time frame: 3 months post op
Range of Motion
Time frame: 3 months post op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Arista in people with Blood Loss, Surgical, run by Virtua Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Loss (time frame: Time of incision until 90 days post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.