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Cell Saver Use in Bilateral Total Hip Arthroplasty (THA)

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01468129
Enrollment
Unknown
Registered
2011-11-09
Start date
2011-11-30
Completion date
2012-12-31
Last updated
2011-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

One-stage Bilateral Total Hip Replacement

Brief summary

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

Interventions

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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

Countries

United States

Contacts

Primary ContactTiffany Morrison, MS
tiffany.morrison@rothmaninstitute.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026