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Cell Saver Use in Bilateral Total Hip Arthroplasty (THA)

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ClinicalTrials.gov Identifier: NCT01468129
Recruitment Status : Unknown
Verified November 2011 by Rothman Institute Orthopaedics.
Recruitment status was:  Recruiting
First Posted : November 9, 2011
Last Update Posted : November 9, 2011
Information provided by:
Rothman Institute Orthopaedics

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

Condition or disease Intervention/treatment
One-stage Bilateral Total Hip Replacement Other: Cell Saver

Study Type : Interventional  (Clinical Trial)
Official Title: A Prospective, Randomized Controlled Trial to Evaluate the Efficacy of Cell Saver to Redue Blood Loss in One-stage Bilateral Total Hip Arthroplasty (THA)
Study Start Date : November 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Active Comparator: Cell Saver Other: Cell Saver
No Intervention: Non Cell Saver

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468129

Contact: Tiffany Morrison, MS tiffany.morrison@rothmaninstitute.com

United States, Pennsylvania
Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Javad Parvizi, MD, FRCS         
Sub-Investigator: William Hozack, MD         
Sub-Investigator: James Purtill, MD         
Sub-Investigator: Matthew Austin, MD         
Sponsors and Collaborators
Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier: NCT01468129     History of Changes
Other Study ID Numbers: 11UJPAR
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: November 2011