Status:
UNKNOWN
Cell Saver Use in Bilateral Total Hip Arthroplasty (THA)
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
One-stage Bilateral Total Hip Replacement
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This study will investigate the efficacy of using cell saver during bilater total hip arthroplasty
Eligibility Criteria
Inclusion
- Subject is over 21 years of age
- 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
- Subject with significant comorbidities identified by Charleston index of ≥ 3
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01468129
Start Date
November 1 2011
End Date
December 1 2012
Last Update
November 9 2011
Active Locations (1)
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1
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107