Thromboelastography-Guided Fluid Management in Spinal Surgery
- Conditions
- Spinal Fusion
- Registration Number
- NCT03999086
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- patients with tumors, infection, or trauma
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Volume of transfused packed red blood cells post operative approximately 1 day Amount of transfused packed red blood cells measured in units of cc(mL)
Estimated Blood Loss post operative approximately 1 day Amount of blood loss measured in units of cc(mL)
Adverse Events One year Number of adverse events reported
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic🇺🇸Scottsdale, Arizona, United States