Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Cell Saver

    Device

    Using Cell Saver during surgery

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Cell SaverActive comparator 1 intervention
Group B: No Cell SaverNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Measure the impact of intraoperative salvaged red blood cells on resuscitation

Measure the impact of intraoperative salvaged red blood cells on resuscitation and whether the return of salvaged red blood cells decreases the amount of intraoperative and postoperative allogenic packed red blood cell transfusions to confirm if any allogenic blood product was provided.

Time frame
2 years

Secondary outcomes

1

Compare complication rates and other secondary outcomes

Via chart review, compare infection, acute kidney injury, thrombocytopenia, liver injury, cardiac events, thrombotic events, pulmonary complications, length of hospital stay, discharge disposition, and 30-day readmission rates of patients who receive salvaged red blood cells versus those who did not.

Time frame
2 years
2

Measure the number of salvaged blood cell units transfused during the hospital stay.

Measure the number of salvaged blood cell units transfused during the hospital stay.

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: