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)

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

Study Overview

• Status: Unknown
• Conditions: One-stage Bilateral Total Hip Replacement
• Intervention / Treatment: Other: Cell Saver

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cell Saver	Other: Cell Saver
No Intervention: Non Cell Saver

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012

Study Registration Dates

• First Submitted: November 7, 2011
• First Submitted That Met QC Criteria: November 8, 2011
• First Posted (Estimate): November 9, 2011

Study Record Updates

• Last Update Posted (Estimate): November 9, 2011
• Last Update Submitted That Met QC Criteria: November 8, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: 11UJPAR