Cost Effectiveness and Clinical Utility of Cell Saver Use for Two to Three Level Lumbar Fusions
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 10, 2011
CompletedFirst Posted
Study publicly available on registry
October 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedOctober 17, 2011
October 1, 2011
2 years
October 10, 2011
October 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Volume of blood transfused
The total volume of blood and blood products transfused during surgery an during hospitalization will be determined
Hospitalization, range of 3 to 14 days
Secondary Outcomes (2)
Immediate post-op Hematocrit level
Post-operative, range of 1 to 14 days
Immediate post-op Hemoglobin level
Post-operative, range of 1 to 14 days
Study Arms (2)
Cell Saver
ACTIVE COMPARATORPatients will have the use of a cell-saver during surgery
No Cell saver
PLACEBO COMPARATORPatient will not have cell saver available during surgery.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Norton Leatherman Spine Center
Louisville, Kentucky, 40202, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mladen Djurasovic, MD
Norton Leatherman Spine Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2011
First Posted
October 17, 2011
Study Start
October 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
October 17, 2011
Record last verified: 2011-10