Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05258487
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2022-02-07
Brief Title:
The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None