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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Traditional evaluation/standard-of-care evaluation of patients undergoing multi-level spinal fusion surgery. These patients will receive point-of-care laboratory testing. |
| |
| Intervention arm | Utilization of TEG for decision-making regarding intra-operative transfusion in major spinal reconstruction surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Procedure | We will utilize thromboelastography to discern when to transfuse blood products in the setting of multi-level spinal fusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood Loss | Amount of blood loss measured in units of cc(mL) | post operative approximately 1 day |
| Volume of transfused packed red blood cells | Amount of transfused packed red blood cells measured in units of cc(mL) | post operative approximately 1 day |
| Adverse Events | Number of adverse events reported | One year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of Mayo Clinic receiving a multi-level spinal fusion surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Jamal McClendon, Jr., MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D013916 | Thrombelastography |
| D035061 | Control Groups |
| D000067716 | Point-of-Care Testing |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D001780 | Blood Coagulation Tests |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
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|
| Control Group | Other | Laboratory analysis to guide transfusion |
|
|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D012107 | Research Design |
| D019095 | Point-of-Care Systems |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |