Cell Saver Use in Bilateral Total Hip Arthroplasty (THA)

Not Applicable

• Conditions: One-stage Bilateral Total Hip Replacement
• Interventions: Other: Cell Saver

• Registration Number: NCT01468129
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-11
• Study Start: 2011-11
• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2011-11-08
• Last Update Submitted: 2011-11-08
• Study First Posted: 2011-11-09
• Last Update Posted: 2011-11-09
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cell Saver	Cell Saver	-

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States