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

NCT01453309 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2011-10-17

No results posted yet for this 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.

Conditions

  • Low Back Pain Unresponsive to Non-surgical Care

Interventions

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.

PROCEDURE

No Cell Saver

Cell Saver will not be available during surgery

Sponsors & Collaborators

  • Norton Leatherman Spine Center

    lead OTHER

Principal Investigators

  • Mladen Djurasovic, MD · Norton Leatherman Spine Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01453309 on ClinicalTrials.gov