Thromboelastography-Guided Fluid Management in Spinal Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Fusion
• Intervention / Treatment: Other: Control Group; Procedure: Intervention

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients of Mayo Clinic receiving a multi-level spinal fusion surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Control Group; Laboratory analysis to guide transfusion; Other Names: Point of care testing
Intervention arm; Utilization of TEG for decision-making regarding intra-operative transfusion in major spinal reconstruction surgery.	Procedure: Intervention; We will utilize thromboelastography to discern when to transfuse blood products in the setting of multi-level spinal fusion; Other Names: Thromboelastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jamal McClendon, Jr., MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2018
• Primary Completion (Actual): November 8, 2019
• Study Completion (Actual): November 8, 2019

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 17-006702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No