---
title: The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery
nct_id: NCT05258487
overall_status: COMPLETED
sponsor: University of Maryland, Baltimore
study_type: OBSERVATIONAL
primary_condition: Intraoperative Blood Loss
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05258487.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05258487"
ct_last_update_post_date: 2024-05-13
last_seen_at: "2026-05-12T06:38:37.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

**NCT ID:** [NCT05258487](https://clinicaltrials.gov/study/NCT05258487)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 121
- **Lead Sponsor:** University of Maryland, Baltimore
- **Collaborators:** Baxter Healthcare Corporation
- **Conditions:** Intraoperative Blood Loss, Thoracolumbar Spine Surgery
- **Start Date:** 2022-03-01
- **Completion Date:** 2023-03-14
- **CT.gov Last Update:** 2024-05-13

## Brief Summary

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

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 88 Years
- **Sex:** ALL
- **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
```

## Arms

- **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.

## Primary Outcomes

- **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.

## Secondary Outcomes

- **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.)_

## Locations (1)

- University of Maryland Medical Center, Baltimore, Maryland, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of maryland medical center|baltimore|maryland|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05258487.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05258487*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*