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Completed

NCT Number: NCT05258487

The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery

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).

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Key information

Conditions

Intraoperative Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Thoracolumbar Spine Surgery

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Receiving Perioperative Blood Transfusion

    Time frame: 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 outcomes

  1. Total Estimated Blood Loss During Surgery (mL)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2022
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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