Intraoperative Blood LossNCT05258487
The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery
An observational study of Intraoperative Blood Loss and Thoracolumbar Spine Surgery, run by University of Maryland, Baltimore at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Intraoperative Blood Loss, Thoracolumbar Spine Surgery
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 14 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective open, posterior thoracolumbar surgery
Who may be able to join
- Ages 18 to 88 years
- Patients receiving elective open, posterior thoracolumbar surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
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).
Read the 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.
- Keywords
- Blood Loss, Thoracolumbar Spine Surgery, VIBe, Blood Transfusion
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VIBe Grade 1 | Intraoperative bleeding of grade 1 as defined by the VIBe scale. | |
| VIBe Grade 2 | Intraoperative bleeding of grade 2 as defined by the VIBe scale. | |
| VIBe Grade 3 | Intraoperative bleeding of grade 3 as defined by the VIBe scale. | |
| VIBe Grade 4 | Intraoperative bleeding of grade 4 as defined by the VIBe scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From day of surgery until discharge from hospital, assessed up to 2 weeks following surgery.
Secondary outcomes (1)
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).
Measured: From the start to the end of surgery, assessed up to 1 day following surgery when estimated blood loss is reported and documented.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Mar 2022
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraoperative Blood LossStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Steven Ludwig, University of Maryland, Baltimore
- Investigators
- Steven C Ludwig, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258487
- Sponsor's protocol ID
- HP-00097392
- Status last verified
- May 2024
- First submitted
- 7 Feb 2022
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27839931
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of the Validated Intraoperative Bleeding Scale in Spine Surgery
- ClinicalTrials.gov ID
- NCT05258487
- Acronym / sponsor ID
- HP-00097392
- Keywords
- Blood Loss, Thoracolumbar Spine Surgery, VIBe, Blood Transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VIBe Grade 1 | – | –Intraoperative bleeding of grade 1 as defined by the VIBe scale. |
| VIBe Grade 2 | – | –Intraoperative bleeding of grade 2 as defined by the VIBe scale. |
| VIBe Grade 3 | – | –Intraoperative bleeding of grade 3 as defined by the VIBe scale. |
| VIBe Grade 4 | – | –Intraoperative bleeding of grade 4 as defined by the VIBe scale. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective open, posterior thoracolumbar surgery
Key inclusion criteria (2 listed)
- Ages 18 to 88 years
- Patients receiving elective open, posterior thoracolumbar surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 27839931Lewis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven C Ludwig, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Blood Loss and Thoracolumbar Spine Surgery, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receiving Perioperative Blood Transfusion (time frame: From day of surgery until discharge from hospital, assessed up to 2 weeks following surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05258487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.