Transmission, Blood, Recipient/DonorNCT01756976
Clinical Evaluation of the OrthoPAT Advance System
An observational study of Transmission, Blood, Recipient/Donor, run by Haemonetics Corporation at 1 site in United States.
Trial summary
This study is intended to provide additional performance data of the OrthoPAT Advance in routine orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Transmission, Blood, Recipient/Donor
- What is being tested?
- OrthoPat Advance
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Aug 2013
- Phase
- Observational
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects scheduled for hysterectomy or orthopediac procedures.
Who may be able to join
- Male or female over the age of 18 years
- Subject is scheduled for a total knee/hip replacement/ revision or a hysterectomy.
- Subjects determined eligible per site standard of care for use of intra- and post-operative use of cell salvage device
Who cannot join
- For subjects where product is transfused
- Subject is undergoing a trauma procedure where there is a possibility of contamination from an open wound.
- Patient is diagnosed with sepsis.
- Patient is diagnosed with sickle-cell anemia.
- Malignant cells may be mixed with blood salvaged from the surgical field.
- Prostatic or amniotic fluid is mixed with blood salvaged from the surgical field.
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- Blood salvaged from the surgical field may be contaminated from an active infection at wound/drain site.
- Blood salvaged from the surgical field contains topical hemostatic agents, anti-bacterial agents, or wound irrigants not intended for parenteral use.
- For all subjects:
- Subject is undergoing a procedure which involves high, rapid blood loss such as liver transplants, certain cardiovascular procedures, and trauma procedures where blood loss is high (per Investigators judgment).
- Any procedure terminated prior to completion by subject request, operator decision or error, or device error.
- Any subject with which at least 200mL of filtered blood or 1 full disc is not available for processing and data collection within the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
This study is intended to provide additional performance data of the OrthoPAT Advance in routine orthopedic surgery.
Read the detailed description
The OrthoPAT Advance system is being developed by Haemonetics to change the user interface, especially for adding calculations for Estimating Blood Loss- (EBL). The OrthoPAT® serves as the predicate device. The following items will be changed in the OrthoPAT Advance system compared to OrthoPAT:
- Software \& User Interface - ability to enter irrigant and anti-coagulant volumes and allow Estimated Blood Loss (EBL) calculation to be made by OrthoPAT Advance.
- Hardware -
- Redesign of reservoir and filter to process blood earlier by reducing hold-up volume and improve fluid visualization in reservoir.
- Extended battery life.
It is not intended to validate the major changes in the OrthoPAT Advance device (reservoir / filter and EBL), which will be conducted as lab based tests. The correct functioning of the reservoir / filter and EBL changes will be confirmed in the clinical setting in this study. However the most rigorous challenge to the filter will be by presenting the worst case media and this can only be controlled in the laboratory.
- Conditions
- Transmission, Blood, Recipient/Donor
- Being tested
- OrthoPat Advance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthoPat AdvanceDevice
The device will be used initially in hysterectomy procedures. After a confirmation of product quality, the device will be used in routine orthopedic procedures.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device | The 510k cleared OrthoPAT Advance will be used in this standard of care arm. Receives: Device: OrthoPat Advance | |
| Control Group | The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Washed RBC Hematocrit
The Hematocrit of the RBC shall be > 50%.
Measured: < 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2013
- Study completionAug 2013
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 Transmission, Blood, Recipient/DonorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haemonetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Waters, MD, Principal investigator, University of Pittsburgh Medial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756976
- Sponsor's protocol ID
- TP-CLN-100257
- Status last verified
- Sep 2013
- First submitted
- 26 Nov 2012
- Last updated
- 20 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the OrthoPAT Advance System
- ClinicalTrials.gov ID
- NCT01756976
- Acronym / sponsor ID
- TP-CLN-100257
- Conditions
- Transmission, Blood, Recipient/Donor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Haemonetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 28 Dec 2012 (estimated)
- Results
- Posted 20 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to provide additional performance data of the OrthoPAT Advance in routine orthopedic surgery.
Detailed description
The OrthoPAT Advance system is being developed by Haemonetics to change the user interface, especially for adding calculations for Estimating Blood Loss- (EBL). The OrthoPAT® serves as the predicate device. The following items will be changed in the OrthoPAT Advance system compared to OrthoPAT:
- Software \& User Interface - ability to enter irrigant and anti-coagulant volumes and allow Estimated Blood Loss (EBL) calculation to be made by OrthoPAT Advance.
- Hardware -
- Redesign of reservoir and filter to process blood earlier by reducing hold-up volume and improve fluid visualization in reservoir.
- Extended battery life.
It is not intended to validate the major changes in the OrthoPAT Advance device (reservoir / filter and EBL), which will be conducted as lab based tests. The correct functioning of the reservoir / filter and EBL changes will be confirmed in the clinical setting in this study. However the most rigorous challenge to the filter will be by presenting the worst case media and this can only be controlled in the laboratory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | – | Device: OrthoPat AdvanceThe 510k cleared OrthoPAT Advance will be used in this standard of care arm. |
| Control Group | – | –The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects scheduled for hysterectomy or orthopediac procedures.
Key inclusion criteria (3 listed)
- Male or female over the age of 18 years
- Subject is scheduled for a total knee/hip replacement/ revision or a hysterectomy.
- Subjects determined eligible per site standard of care for use of intra- and post-operative use of cell salvage device
Key exclusion criteria (12 listed)
- For subjects where product is transfused
- Subject is undergoing a trauma procedure where there is a possibility of contamination from an open wound.
- Patient is diagnosed with sepsis.
- Patient is diagnosed with sickle-cell anemia.
- Malignant cells may be mixed with blood salvaged from the surgical field.
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 |
|---|---|---|
| OrthoPat AdvanceThe device will be used initially in hysterectomy procedures. After a confirmation of product quality, the device will be used in routine orthopedic procedures. | Device | Investigational Device |
Primary outcome
Washed RBC Hematocrit
Time frame: < 4 hours
The Hematocrit of the RBC shall be > 50%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jonathan Waters, MD principal investigator
University of Pittsburgh Medial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transmission, Blood, Recipient/Donor, run by Haemonetics Corporation 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 3 inclusion and 12 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 20 Nov 2013. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2013). 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?
Washed RBC Hematocrit (time frame: < 4 hours). 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 20 Nov 2013.