The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05258487

Enrollment

121

Registered

2022-02-28

Start date

2022-03-01

Completion date

2023-03-14

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Blood Loss, Thoracolumbar Spine Surgery

Keywords

Blood Loss, Thoracolumbar Spine Surgery, VIBe, Blood Transfusion

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 88 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

United States

Outcome results