The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

Intraoperative Blood Loss Clinical Trial

Official title:

The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05258487
• Other study ID #: HP-00097392
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: March 14, 2023

Study information

• Verified date: May 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 14, 2023
• Est. primary completion date: March 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Intraoperative Blood Loss

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total Estimated Blood Loss During Surgery (mL)	The secondary outcome will be total blood loss during surgery assessed using anesthesiology and surgeon reported estimated blood loss (mL).	From the start to the end of surgery, assessed up to 1 day following surgery when estimated blood loss is reported and documented.