The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

Completed

• Conditions: Thoracolumbar Spine Surgery; Intraoperative Blood Loss

• Registration Number: NCT05258487
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-28
• Study Start: 2022-03-01
• Primary Completion: 2023-03-14
• Study Completion: 2023-03-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Receiving Perioperative Blood Transfusion	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 Outcome Measures

Name	Time	Method
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.	The secondary outcome will be total blood loss during surgery assessed using anesthesiology and surgeon reported estimated blood loss (mL).

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States