The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

Conditions
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Intraoperative Blood Loss, Thoracolumbar Spine Surgery

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VIBe Grade 1<br>Intraoperative bleeding of grade 1 as defined by the VIBe scale. | |
| VIBe Grade 2<br>Intraoperative bleeding of grade 2 as defined by the VIBe scale. | |
| VIBe Grade 3<br>Intraoperative bleeding of grade 3 as defined by the VIBe scale. | |
| VIBe Grade 4<br>Intraoperative bleeding of grade 4 as defined by the VIBe scale. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receiving Perioperative Blood Transfusion | 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) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Loss, Thoracolumbar Spine Surgery, VIBe, Blood Transfusion