SALVAGE Trial (Safety And cLinical Value of AutoloGous rEinfusion)
ConditionAdult Spinal Deformity Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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
Qualifiers
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).
Disqualifiers
Patients with active spinal infection, neoplasm, acute trauma, neuromuscular etiology, syndromic scoliosis, prisoners, and pregnant patients
Trial design
Treatments tested in this trial
- Cell Saver
Treatment groups
146 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov