Skip to main content
OpenTrials
Completed

NCT Number: NCT03999086

Thromboelastography-Guided Fluid Management in Spinal Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Fusion

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Procedure

We will utilize thromboelastography to discern when to transfuse blood products in the setting of multi-level spinal fusion

Other names: Thromboelastography

Control Group

Other

Laboratory analysis to guide transfusion

Other names: Point of care testing

Primary outcomes

  1. Estimated Blood Loss

    Time frame: post operative approximately 1 day

    Amount of blood loss measured in units of cc(mL)

  2. Volume of transfused packed red blood cells

    Time frame: post operative approximately 1 day

    Amount of transfused packed red blood cells measured in units of cc(mL)

  3. Adverse Events

    Time frame: One year

    Number of adverse events reported

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2019
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.