The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery
NCT ID: NCT05258487
Last Updated: 2024-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
121 participants
OBSERVATIONAL
2022-03-01
2023-03-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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VIBe Grade 1
Intraoperative bleeding of grade 1 as defined by the VIBe scale.
No interventions assigned to this group
VIBe Grade 2
Intraoperative bleeding of grade 2 as defined by the VIBe scale.
No interventions assigned to this group
VIBe Grade 3
Intraoperative bleeding of grade 3 as defined by the VIBe scale.
No interventions assigned to this group
VIBe Grade 4
Intraoperative bleeding of grade 4 as defined by the VIBe scale.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients receiving elective open, posterior thoracolumbar surgery
Exclusion Criteria
* 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
18 Years
88 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
University of Maryland, Baltimore
OTHER
Responsible Party
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Steven Ludwig
Chief of Spine Surgery, Professor
Principal Investigators
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Steven C Ludwig, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Locations
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University of Maryland Medical Center
Baltimore, Maryland, United States
Countries
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References
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Lewis KM, Li Q, Jones DS, Corrales JD, Du H, Spiess PE, Lo Menzo E, DeAnda A Jr. Development and validation of an intraoperative bleeding severity scale for use in clinical studies of hemostatic agents. Surgery. 2017 Mar;161(3):771-781. doi: 10.1016/j.surg.2016.09.022. Epub 2016 Nov 10.
Other Identifiers
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HP-00097392
Identifier Type: -
Identifier Source: org_study_id
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