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Clinical Trials/NCT01468129
NCT01468129
Unknown
N/A

A Prospective, Randomized Controlled Trial to Evaluate the Efficacy of Cell Saver to Redue Blood Loss in One-stage Bilateral Total Hip Arthroplasty (THA)

Rothman Institute Orthopaedics1 site in 1 countryNovember 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
One-stage Bilateral Total Hip Replacement
Sponsor
Rothman Institute Orthopaedics
Locations
1
Last Updated
14 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
December 2012
Last Updated
14 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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