SALVAGE Trial (Safety And cLinical Value of AutoloGous rEinfusion) (SALVAGE)

July 14, 2026 updated by: Anthony L. Mikula, Mayo Clinic

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The goals of this study would therefore be to:

  1. 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.
  2. 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.
  3. Determine if there's a threshold of transfused cell salvage blood that may be beneficial (e.g. <300ml) and avoids complications.

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cell Saver
Randomized to utilize cell savor intraoperatively
Device: Cell Saver
Using Cell Saver during surgery
No Intervention: No Cell Saver
Control Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Anthony Mikula, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-004500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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