Thromboelastography-Guided Fluid Management in Spinal Surgery

NCT03999086 | Completed

• 1 other identifier: 17-006702
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Fusion

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Intervention arm

Utilization of TEG for decision-making regarding intra-operative transfusion in major spinal reconstruction surgery.

Procedure: Intervention

Interventions

Intervention PROCEDURE

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

Also known as: Thromboelastography

Intervention arm

Control Group OTHER

Laboratory analysis to guide transfusion

Also known as: Point of care testing

Control Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• patients with tumors, infection, or trauma

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Methods; Thrombelastography; Control Groups; Point-of-Care Testing

Intervention Hierarchy (Ancestors)

Investigative Techniques; Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Officials

• Jamal McClendon, Jr., MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: June 26, 2019
• Study Start: January 12, 2018
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: February 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)