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Clinical Evaluation of the OrthoPAT Advance System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01756976
Recruitment Status : Completed
First Posted : December 28, 2012
Results First Posted : November 20, 2013
Last Update Posted : November 20, 2013
Information provided by (Responsible Party):
Haemonetics Corporation

Brief Summary:
This study is intended to provide additional performance data of the OrthoPAT Advance in routine orthopedic surgery.

Condition or disease Intervention/treatment
Transmission, Blood, Recipient/Donor Device: OrthoPat Advance

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.

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Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of the OrthoPAT Advance System
Study Start Date : December 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Group/Cohort Intervention/treatment
Investigational Device
The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
Device: 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.

Primary Outcome Measures :
  1. Washed RBC Hematocrit [ Time Frame: < 4 hours ]
    The Hematocrit of the RBC shall be > 50%.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects scheduled for hysterectomy or orthopediac procedures.

Inclusion Criteria:

  • 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

Exclusion Criteria:

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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01756976

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United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Haemonetics Corporation
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Principal Investigator: Jonathan Waters, MD University of Pittsburgh Medial Center
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Responsible Party: Haemonetics Corporation Identifier: NCT01756976    
Other Study ID Numbers: TP-CLN-100257
First Posted: December 28, 2012    Key Record Dates
Results First Posted: November 20, 2013
Last Update Posted: November 20, 2013
Last Verified: September 2013