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NCT03999086 Clinical Trial

Thromboelastography-Guided Fluid Management in Spinal Surgery

Spinal Fusion Clinical Trial

Official title:
Thromboelastography-guided Fluid Management in Spinal Surgery: A Prospective Analysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03999086
Other study ID # 17-006702
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 12, 2018
Est. completion date November 8, 2019

Study information
Verified date February 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 50
Est. completion date November 8, 2019
Est. primary completion date November 8, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Intervention
We will utilize thromboelastography to discern when to transfuse blood products in the setting of multi-level spinal fusion
Other:
• Control Group
Laboratory analysis to guide transfusion

Locations
Country Name City State
United States Mayo Clinic Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Estimated Blood Loss Amount of blood loss measured in units of cc(mL) post operative approximately 1 day
Primary 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
Primary Adverse Events Number of adverse events reported One year
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