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Cell Saver for Chronic Low Back Pain
N/A
Waitlist Available
Led By Mladen Djurasovic, MD
Research Sponsored by Norton Leatherman Spine Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative, range of 1 to 14 days
Awards & highlights
Study 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.
Eligible Conditions
- Chronic Low Back Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative, range of 1 to 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative, range of 1 to 14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Volume of blood transfused
Secondary outcome measures
Immediate post-op Hematocrit level
Immediate post-op Hemoglobin level
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Cell SaverActive Control1 Intervention
Patients will have the use of a cell-saver during surgery
Group II: No Cell saverPlacebo Group1 Intervention
Patient will not have cell saver available during surgery.
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Who is running the clinical trial?
Norton Leatherman Spine CenterLead Sponsor
5 Previous Clinical Trials
537 Total Patients Enrolled
Mladen Djurasovic, MDPrincipal InvestigatorNorton Leatherman Spine Center
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