Clinical Evaluation of the OrthoPAT Advance System
Completed
Conditions studied: Transmission, Blood, Recipient/Donor
In brief
This study is intended to provide additional performance data of the OrthoPAT Advance in routine orthopedic surgery.
Key facts
- Study ID
- NCT01756976
- Run by
- Haemonetics Corporation
- People needed
- 84
- Starts
- 2012-12-01
- Expected to finish
- 2013-08-01
- Last updated by the study team
- 2013-11-20
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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