Cell Saver Use in Bilateral Total Hip Arthroplasty (THA)
This study is currently recruiting participants.
Verified November 2011 by Rothman Institute Orthopaedics
Sponsor:
Rothman Institute Orthopaedics
Information provided by:
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT01468129
First received: November 7, 2011
Last updated: November 8, 2011
Last verified: November 2011
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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
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 May 16, 2013