The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Intraoperative Blood Loss; Thoracolumbar Spine Surgery

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05258487

HP-00097392

Details and patient eligibility

About

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).

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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

Trial design

121 participants in 4 patient groups

VIBe Grade 1

Description:

Intraoperative bleeding of grade 1 as defined by the VIBe scale.

VIBe Grade 2

Description:

Intraoperative bleeding of grade 2 as defined by the VIBe scale.

VIBe Grade 3

Description:

Intraoperative bleeding of grade 3 as defined by the VIBe scale.

VIBe Grade 4

Description:

Intraoperative bleeding of grade 4 as defined by the VIBe scale.