Cell Saver Use in Bilateral Total Hip Arthroplasty (THA)
NCT ID: NCT01468129
Last Updated: 2011-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
INTERVENTIONAL
2011-11-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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Cell Saver
Cell Saver
Non Cell Saver
No interventions assigned to this group
Interventions
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Cell Saver
Eligibility Criteria
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Inclusion Criteria
* Subject with bilateral degenerative disease of hips who are candidate for one-stage bilateral THA
* Subject willing and able to provide written informed consent
Exclusion Criteria
* Subject with malignancy
* Subject with history of heart disease, myocardial infarction, pulmonary insufficiency, pulmonary embolus, documented fat emboli syndrome, adult respiratory distress syndrome, documented patent ductus arteriosus or septal defect, chronic renal failure and/or acute hepatic failure or chirhosis
* Subjects with hematologic disorders such as anemia (Hb \< 10 g/dL) and sickle cell disease, acquired or congenital coagulopathies, acquired or congenital bleeding disorders,
* Subject who received anticoagulant such as aspirin or Warfarin (Coumadin) or antiplatelet agents such as clopidogrel (Plavix) within 7 days of surgery
* Subject who received hemostatic agents such as tranexamic acid and aprotinin
* Subjects utilizing acute normovolumic haemodilution
* Subject is not permitted to remain without his/her anti-coagulant regimen (eg Plavix) for 48 hours postoperatively
* Subject is known to be pregnant.
* Subject has erythropoietin agonist/stimulating agent within 90 days prior to surgery.
* Presence of contaminants such as urine, fat, bowel contents, and most importantly infection in the operative field
* Presence of vasoactive drugs such as papaverine in the operative field
21 Years
ALL
No
Sponsors
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Rothman Institute Orthopaedics
OTHER
Locations
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Rothman Institute
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Other Identifiers
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11UJPAR
Identifier Type: -
Identifier Source: org_study_id