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NCT Number: NCT07712666

SALVAGE Trial (Safety And cLinical Value of AutoloGous rEinfusion)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The goals of this study would therefore be to:

  • Determine 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, both in terms of whether any allogenic blood product was provided and the number of units transfused during the hospital stay.
  • Compare complication rates and other secondary outcomes between patients who receive salvaged red blood cells versus those who did not, including infection, acute kidney injury, thrombocytopenia, liver injury, cardiac events, thrombotic events, pulmonary complications, length of hospital stay, discharge disposition, and 30-day readmission rates.
  • Determine if there's a threshold of transfused cell salvage blood that may be beneficial (e.g. <300ml) and avoids complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cell Saver

Device

Using Cell Saver during surgery

Primary outcomes

  1. Measure the impact of intraoperative salvaged red blood cells on resuscitation

    Time frame: 2 years

    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.

Secondary outcomes

  1. Compare complication rates and other secondary outcomes

    Time frame: 2 years

    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.

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

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Justice Story

CONTACT

[email protected]

507-422-5528

Laura Westendorf

CONTACT

[email protected]

507-284-8167

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

SALVAGE Trial (Safety And cLinical Value of AutoloGous rEinfusion): A Multicenter, Randomized, Open-Label, Parallel-Group Trial Comparing Intraoperative Cell Salvage Versus No Cell Salvage in Adult Spinal Deformity Surgery

Acronym: SALVAGE

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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