Cell Saver Use in Bilateral Total Hip Arthroplasty (THA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Rothman Institute Orthopaedics.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT01468129
First received: November 7, 2011
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention
One-stage Bilateral Total Hip Replacement
Other: Cell Saver

Study Type: Interventional
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)

Further study details as provided by Rothman Institute Orthopaedics:

Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cell Saver Other: Cell Saver
No Intervention: Non Cell Saver

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468129

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

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01468129     History of Changes
Other Study ID Numbers: 11UJPAR
Study First Received: November 7, 2011
Last Updated: November 8, 2011
Health Authority: USA: Institutional Review Board

ClinicalTrials.gov processed this record on August 21, 2014