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Cell Saver Use in Bilateral Total Hip Arthroplasty (THA)

Rothman Institute Orthopaedics logo

Rothman Institute Orthopaedics

Status

Unknown

Conditions

One-stage Bilateral Total Hip Replacement

Treatments

Other: Cell Saver

Study type

Interventional

Funder types

Other

Identifiers

NCT01468129
11UJPAR

Details and patient eligibility

About

This study will investigate the efficacy of using cell saver during bilater total hip arthroplasty

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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

Trial design

0 participants in 2 patient groups

Cell Saver
Active Comparator group
Treatment:
Other: Cell Saver
Non Cell Saver
No Intervention group

Trial contacts and locations

1

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Central trial contact

Tiffany Morrison, MS

Data sourced from clinicaltrials.gov

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