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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective open, posterior thoracolumbar surgery
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| Name | Affiliation | Role |
|---|---|---|
| Steven C Ludwig, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27839931 | Background | 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. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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