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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01453309
Recruitment Status : Unknown
Verified October 2011 by Norton Leatherman Spine Center.
Recruitment status was:  Not yet recruiting
First Posted : October 17, 2011
Last Update Posted : October 17, 2011
Information provided by (Responsible Party):
Norton Leatherman Spine Center

Brief Summary:
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 or disease Intervention/treatment Phase
Low Back Pain Unresponsive to Non-surgical Care Procedure: Cell Saver Procedure: No Cell Saver Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cost Effectiveness and Clinical Utility of Cell Saver Use for Two to Three Level Lumbar Fusions
Study Start Date : October 2011
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Volume of blood transfused [ Time Frame: Hospitalization, range of 3 to 14 days ]
    The total volume of blood and blood products transfused during surgery an during hospitalization will be determined

Secondary Outcome Measures :
  1. Immediate post-op Hematocrit level [ Time Frame: Post-operative, range of 1 to 14 days ]
    Immediate post-op Hematocrit level

  2. Immediate post-op Hemoglobin level [ Time Frame: Post-operative, range of 1 to 14 days ]
    Immediate post-op Hemoglobin level

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01453309

Contact: Leah Y Carreon, MD, MSc 502 992 0488 ext 139
Contact: Kelly R Bratcher, RN 502 992 0488 ext 131

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
Principal Investigator: Mladen Djurasovic, MD Norton Leatherman Spine Center

Responsible Party: Norton Leatherman Spine Center Identifier: NCT01453309     History of Changes
Other Study ID Numbers: 11-N0216
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: October 2011

Keywords provided by Norton Leatherman Spine Center:
lumbar fusion

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