The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

May 9, 2024 updated by: Steven Ludwig, University of Maryland, Baltimore
This is a single-center, prospective, observational study that will compare the blood transfusion rate between intraoperative bleeding severity characterized using the Validated Intraoperative Bleeding Scale (VIBe).

Study Overview

Status

Completed

Conditions

Detailed Description

Primary Aim: Assess the association between the VIBe scale and intraoperative and postoperative blood transfusion rates for posterior thoracolumbar spine surgery.

Primary Hypothesis: Patients with higher recorded VIBe grades during the five stages of spine surgery (exposure, decompression, instrumentation, fusion, and closing) will have a higher rate of receiving blood transfusions.

Secondary Aims: Determine the association between the VIBe scale and other postoperative outcomes and complications.

Study Type

Observational

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective open, posterior thoracolumbar surgery

Description

Inclusion Criteria:

  • Ages 18 to 88 years
  • Patients receiving elective open, posterior thoracolumbar surgery

Exclusion Criteria:

  • Patients receiving non-elective or trauma surgery
  • Patients with pathologic spine fracture or metastatic disease to the spine
  • Patients receiving thoracolumbar surgery through anterior or lateral approach
  • Patients receiving spine surgery for debridement of suspected or confirmed infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
VIBe Grade 1
Intraoperative bleeding of grade 1 as defined by the VIBe scale.
VIBe Grade 2
Intraoperative bleeding of grade 2 as defined by the VIBe scale.
VIBe Grade 3
Intraoperative bleeding of grade 3 as defined by the VIBe scale.
VIBe Grade 4
Intraoperative bleeding of grade 4 as defined by the VIBe scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receiving Perioperative Blood Transfusion
Time Frame: From day of surgery until discharge from hospital, assessed up to 2 weeks following surgery.
The main outcome will be whether or not the patient received a blood transfusion during the surgery or the postoperative hospitalization period.
From day of surgery until discharge from hospital, assessed up to 2 weeks following surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Estimated Blood Loss During Surgery (mL)
Time Frame: From the start to the end of surgery, assessed up to 1 day following surgery when estimated blood loss is reported and documented.
The secondary outcome will be total blood loss during surgery assessed using anesthesiology and surgeon reported estimated blood loss (mL).
From the start to the end of surgery, assessed up to 1 day following surgery when estimated blood loss is reported and documented.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: Steven C Ludwig, MD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

March 14, 2023

Study Completion (Actual)

March 14, 2023

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00097392

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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