Thromboelastography-Guided Fluid Management in Spinal Surgery

Completed

• Conditions: Spinal Fusion
• Interventions: Procedure: Intervention; Other: Control Group

• 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.

Study Timeline

• Study Start: 2018-01-12
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-26
• Primary Completion: 2019-11-08
• Study Completion: 2019-11-08
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention arm	Intervention	Utilization of TEG for decision-making regarding intra-operative transfusion in major spinal reconstruction surgery.
Control Group	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.

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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States