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Thromboelastography-Guided Fluid Management in Spinal Surgery

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03999086
Collaborator
(none)
50
Enrollment
1
Location
21.8
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intervention
  • Other: Control Group

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 Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Thromboelastography-guided Fluid Management in Spinal Surgery: A Prospective Analysis
Actual Study Start Date :
Jan 12, 2018
Actual Primary Completion Date :
Nov 8, 2019
Actual Study Completion Date :
Nov 8, 2019

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Estimated Blood Loss [post operative approximately 1 day]

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

    2. 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)

    3. Adverse Events [One year]

      Number of adverse events reported

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Scottsdale Arizona United States 85259

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Jamal McClendon, Jr., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03999086
    Other Study ID Numbers:
    • 17-006702
    First Posted:
    Jun 26, 2019
    Last Update Posted:
    Feb 2, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 2, 2021