Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
84 participants
OBSERVATIONAL
2012-12-31
2013-08-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Investigational Device
The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
OrthoPat Advance
The device will be used initially in hysterectomy procedures. After a confirmation of product quality, the device will be used in routine orthopedic procedures.
Control Group
The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
No interventions assigned to this group
Interventions
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OrthoPat Advance
The device will be used initially in hysterectomy procedures. After a confirmation of product quality, the device will be used in routine orthopedic procedures.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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.
18 Years
85 Years
ALL
Yes
Sponsors
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Haemonetics Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Waters, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medial Center
Locations
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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TP-CLN-100257
Identifier Type: -
Identifier Source: org_study_id