NCT01468129

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

1.1 years

First QC Date

November 7, 2011

Last Update Submit

November 8, 2011

Conditions

One-stage Bilateral Total Hip Replacement

Study Arms (2)

Cell Saver

ACTIVE COMPARATOR
Other: Cell Saver

Non Cell Saver

NO INTERVENTION

Interventions

Cell SaverOTHER
Cell Saver

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Interventions

Operative Blood Salvage

Intervention Hierarchy (Ancestors)

Tissue and Organ HarvestingTransplantationSurgical Procedures, Operative

Central Study Contacts

Tiffany Morrison, MS

CONTACT

tiffany.morrison@rothmaninstitute.com

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2011

First Posted

November 9, 2011

Study Start

November 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

US(1)