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Not Yet Recruiting NCT07712666

SALVAGE Trial (Safety And cLinical Value of AutoloGous rEinfusion)

Conditions: Adult Spinal Deformity Surgery

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 146
Sponsor: Mayo Clinic

Summary

The investigator hypothesizes intraoperative salvaged red blood cells are a poor substitute for allogenic packed red blood cell transfusions. In addition to providing inadequate resuscitation, salvaged red blood cells can increase the rate of complications, including postoperative electrolyte abnormalities, thrombocytopenia, anemia, and coagulopathy.

Eligibility Criteria

Inclusion Criteria: * Patients \>18 years of age undergoing adult thoracolumbar spinal deformity surgery as defined by one or more of the following radiographic criteria: 1) sagittal vertical axis \> 15 cm, pelvic incidence (PI) minus lumbar lordosis (LL) \> 25°, T1 pelvic angle \> 30°, thoracic scoliosis \> 70°, thoracolumbar/lumbar scoliosis \> 50°, or global coronal alignment \> 7 cm; 2) one or more of the following surgical criteria: posterior spinal fusion \> 12 levels, 3-column osteotomy (3CO), or anterior-column reconstruction; or 3) age \> 65 years and undergoing a minimum of 7 levels of spinal instrumentation surgery (geriatric criteria). Exclusion Criteria: * Patients with active spinal infection, neoplasm, acute trauma, neuromuscular etiology, syndromic scoliosis, prisoners, and pregnant patients

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07712666). StuddyBuddy aggregates publicly available trial information.