Clinical Evaluation of the OrthoPAT Advance System

NCT01756976 | Completed Results

• 1 other identifier: TP-CLN-100257
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transmission, Blood, Recipient/Donor

Outcome Measures

Primary Outcomes (1)

• Washed RBC Hematocrit

  The Hematocrit of the RBC shall be \> 50%.

  < 4 hours

Study Arms (2)

Investigational Device

The 510k cleared OrthoPAT Advance will be used in this standard of care arm.

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.

Interventions

OrthoPat Advance DEVICE

The device will be used initially in hysterectomy procedures. After a confirmation of product quality, the device will be used in routine orthopedic procedures.

Investigational Device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects scheduled for hysterectomy or orthopediac procedures.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haemonetics Corporation: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Haemonetics

michael.dioguardi@haemonetics.com

781-356-9595

Study Officials

• Jonathan Waters, MD

  University of Pittsburgh Medial Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: December 28, 2012
• Study Start: December 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 20, 2013
• Results First Posted: November 20, 2013

Record last verified: 2013-09

Locations

US (1)