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Cost Effectiveness and Clinical Utility of Cell Saver Use for Two to Three Level Lumbar Fusions

This study is not yet open for participant recruitment.
Verified October 2011 by Norton Leatherman Spine Center
Sponsor:
Information provided by (Responsible Party):
Norton Leatherman Spine Center
ClinicalTrials.gov Identifier:
NCT01453309
First received: October 10, 2011
Last updated: October 14, 2011
Last verified: October 2011
History of Changes
  Purpose

The purpose of this study is to determine the cost-effectiveness of using a cell saver for 2 to 3 level lumbar fusions. A secondary objective is to determine if there will be a decrease in the number of allogenic blood transfusions when a cell saver is used intraoperatively. Another secondary objective is to determine incidence of complications associated with cell saver use and transfusions.


Condition Intervention
Low Back Pain Unresponsive to Non-surgical Care
 Procedure: Cell Saver
Procedure: No Cell Saver

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cost Effectiveness and Clinical Utility of Cell Saver Use for Two to Three Level Lumbar Fusions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norton Leatherman Spine Center:

Primary Outcome Measures:
  • Volume of blood transfused [ Time Frame: Hospitalization, range of 3 to 14 days ] [ Designated as safety issue: No ]
    The total volume of blood and blood products transfused during surgery an during hospitalization will be determined


Secondary Outcome Measures:
  • Immediate post-op Hematocrit level [ Time Frame: Post-operative, range of 1 to 14 days ] [ Designated as safety issue: No ]
    Immediate post-op Hematocrit level

  • Immediate post-op Hemoglobin level [ Time Frame: Post-operative, range of 1 to 14 days ] [ Designated as safety issue: No ]
    Immediate post-op Hemoglobin level


Estimated Enrollment: 240
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cell Saver
Patients will have the use of a cell-saver during surgery
 Procedure: Cell Saver
Cell Savers are used intraoperatively to decrease the risk of transfusion due to surgical blood loss. Blood collected from the operative field is anticoagulated, filtered, and stored in a reservoir. Once a set volume of blood has been collected in the reservoir, the blood is separated into its red blood cell and plasma components by use of a centrifuge. Red blood cells are washed with a crystalloid solution and then reinfused into the patient.
Placebo Comparator: No Cell saver
Patient will not have cell saver available during surgery.
 Procedure: No Cell Saver
Cell Saver will not be available during surgery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age at time of enrollment
  • Signed informed consent
  • Requires fusion of 2 to 3 levels from L1-S1 for degenerative lumbar disorders

Exclusion Criteria:

  • Spinal trauma/fracture/malignancy
  • Infection as an indication for surgery
  • Pregnant or nursing women
  • Prisoners
  • Institutionalized in a non-voluntary and/or dependent residence (including hospitals, group homes, etc.), who may not be competent to give informed consent.
  • Inability to speak or understand English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453309

Contacts
Contact: Leah Y Carreon, MD, MSc 502 992 0488 ext 139 leah.carreon@nortonhealthcare.org
Contact: Kelly R Bratcher, RN 502 992 0488 ext 131 kelly.bratcher2@nortonhealthcare.org

Locations
United States, Kentucky
Norton Leatherman Spine Center Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact     502-744-0468        
Principal Investigator: Mladen Djurasovic, MD            
Sub-Investigator: Steven D Glassman, MD            
Sub-Investigator: John R Dimar, MD            
Sub-Investigator: Rolando M Puno, MD            
Sub-Investigator: Mitchell J Campbell, MD            
Sub-Investigator: Charles H Crawford III, MD            
Sub-Investigator: R. Kirk Owens, MD            
Sub-Investigator: Leah Y Carreon, MD. MSc            
Sponsors and Collaborators
Norton Leatherman Spine Center
Investigators
Principal Investigator: Mladen Djurasovic, MD Norton Leatherman Spine Center
  More Information

No publications provided

Responsible Party: Norton Leatherman Spine Center
ClinicalTrials.gov Identifier: NCT01453309     History of Changes
Other Study ID Numbers: 11-N0216
Study First Received: October 10, 2011
Last Updated: October 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Norton Leatherman Spine Center:
lumbar fusion
transfusion
cell-saver
cost-effectiveness

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013