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Clinical Evaluation of the OrthoPAT Advance System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haemonetics Corporation
ClinicalTrials.gov Identifier:
NCT01756976
First received: November 26, 2012
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of the OrthoPAT Advance System

Further study details as provided by Haemonetics Corporation:

Primary Outcome Measures:
  • Washed RBC Hematocrit [ Time Frame: < 4 hours ] [ Designated as safety issue: No ]
    The Hematocrit of the RBC shall be > 50%.


Enrollment: 84
Study Start Date: December 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects scheduled for hysterectomy or orthopediac procedures.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756976

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Haemonetics Corporation
Investigators
Principal Investigator: Jonathan Waters, MD University of Pittsburgh Medial Center
  More Information

No publications provided

Responsible Party: Haemonetics Corporation
ClinicalTrials.gov Identifier: NCT01756976     History of Changes
Other Study ID Numbers: TP-CLN-100257
Study First Received: November 26, 2012
Results First Received: September 17, 2013
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 27, 2014