Spinal Fusion
Conditions
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.
Interventions
PROCEDUREIntervention
We will utilize thromboelastography to discern when to transfuse blood products in the setting of multi-level spinal fusion
OTHERControl Group
Laboratory analysis to guide transfusion
Sponsors
Mayo Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss | post operative approximately 1 day | Amount of blood loss measured in units of cc(mL) |
| 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) |
| Adverse Events | One year | Number of adverse events reported |
Countries
United States
Outcome results
None listed