The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

NCT05258487 | Completed

• 1 other identifier: HP-00097392
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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).

Conditions

Intraoperative Blood Loss; Thoracolumbar Spine Surgery

Keywords

Blood Loss; Thoracolumbar Spine Surgery; VIBe; Blood Transfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total Estimated Blood Loss During Surgery (mL)

  From the start to the end of surgery, assessed up to 1 day following surgery when estimated blood loss is reported and documented.

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective open, posterior thoracolumbar surgery

You may qualify if:

• Ages 18 to 88 years
• Patients receiving elective open, posterior thoracolumbar surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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.

  PMID: 27839931 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven C Ludwig, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Spine Surgery, Professor

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 28, 2022
• Study Start: March 1, 2022
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)