Spinal Deformity
Conditions
Keywords
Red Blood Cells
Brief summary
The actual quality of Red Blood Cells (RBCs) salvaged during spinal deformity surgery has never been rigorously evaluated. To characterize the usefulness of intraoperatively salvaged RBCs in spinal deformity surgery. The study team hopes to answer the following questions: 1) What is the quality of RBCs salvaged during spine surgery? 2) Does intraoperatively transfused RBC salvage impact clinical outcomes?
Interventions
None listed
Sponsors
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any/all patients undergoing spine surgery who utilizes Cell Saver and has blood to be given back. * This will include pediatric patients 0-17 as well as adults of any age who have been indicated for surgery. * Only patients with the capacity to consent will be included.
Exclusion criteria
* Patients indicated for spinal surgery without the use of Cell Saver.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lactate Dehydrogenase (LDH) Levels | Day 1 (Day of Surgery) | LDH assays will be performed following a standardized mechanical stress test will be used to determine whether salvaged red blood cells exhibit signs of fragility ex vivo. |
| Hemoglobin Levels | Day 1 (Day of Surgery) | Hemoglobin assays will be performed following a standardized mechanical stress test will be used to determine whether salvaged red blood cells exhibit signs of fragility ex vivo. |
| Elongation Index (Deformability) | Day 1 (Day of Surgery) | Ektacytometry will be employed to measure elongation index of salvaged RBCs. |
| Critical Shear Stress (Aggregation) | Day 1 (Day of Surgery) | Ektacytometry will be employed to measure critical shear stress of salvaged RBCs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Units of allogeneic blood transfused intraoperatively | Day 1 (Day of Surgery) | — |
| Standardized Quantified Blood Loss (mL) | Day 1 (Day of Surgery) | — |
| Duration of pressor use | 1 Day (Day of Surgery) | — |
| Units of allogeneic blood transfused postoperatively | Day 1 (Day of Surgery) | — |
| Use of Cell Saver | Day 1 (Day of Surgery) | This will be reported in a binary manner: 0 = yes, 1 = no |
| Volume (mL) collected via Cell Saver | Day 1 (Day of Surgery) | — |
| Units of autologous blood transfused intraoperatively | Day 1 (Day of Surgery) | — |
Countries
United States
Outcome results
None listed