Thromboelastography-guided Fluid Management in Spinal Surgery: A Prospective Analysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Fusion
- Sponsor
- Mayo Clinic
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Volume of transfused packed red blood cells
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The Researchers are trying to evaluate whether using a blood test called thromboelastogram (TEG) to manage patients undergoing multi-level spinal fusion surgery will reduce complications after surgery compared with the standard practices.
Detailed Description
Multi-level instrumented spinal fusions represent an important treatment modality for degenerative scoliosis and sagittal malalignment. These surgeries remain a significant physiologic burden with high blood loss and long operative times. Thromboelastography provides a quantitative measure for blood product transfusion surrounding procedures. We aim to utilize thromboelastography to guide transfusions for multi-level spinal instrumentation. This two-arm, randomized, non-blinded prospective analysis will clarify reduced transfusion requirements for TEG-arm compared to non-TEG arm. We will also evaluate postoperative outcomes at the 1 year time-point.
Investigators
Jamal McClendon, Jr.
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •all patients undergoing elective multi-level spinal fusion for sagittal malalignment, multi-level spondylolisthesis, multi-level lumbar spinal stenosis, and adult degenerative scoliosis with ages between 18-89
Exclusion Criteria
- •patients with tumors, infection, or trauma
Outcomes
Primary Outcomes
Volume of transfused packed red blood cells
Time Frame: post operative approximately 1 day
Amount of transfused packed red blood cells measured in units of cc(mL)
Estimated Blood Loss
Time Frame: post operative approximately 1 day
Amount of blood loss measured in units of cc(mL)
Adverse Events
Time Frame: One year
Number of adverse events reported