Purpose

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).

Conditions

Eligibility

Eligible Ages
Between 18 Years and 88 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

More Details

Status
Completed
Sponsor
University of Maryland, Baltimore

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.