Recruiting

Cell Saver

Sponsor:

Rothman Institute Orthopaedics

Code:

NCT01468129

Conditions

One-stage Bilateral Total Hip Replacement

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Cell Saver

Study Details

Brief summary:

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

Conditions

One-stage Bilateral Total Hip Replacement

Study ID

NCT01468129

Start date

Nov, 2011

Status verified date

Nov, 2011

Completion date

Dec, 2012

Primary completion date

Dec, 2012

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Interventions and Outcome Measures

Arms

active comparator: Cell Saver

no intervention: Non Cell Saver

Interventions

Cell Saver

Central Contacts and Locations

Central contacts

Tiffany Morrison, MS

tiffany.morrison@rothmaninstitute.com

Locations

Rothman Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Principal Investigator:

Javad Parvizi, MD, FRCS

More Information

Sponsor

Rothman Institute Orthopaedics

Last update posted

Nov 9, 2011

Last verified

Nov, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rothman Institute Orthopaedics on 2011-11-09.