Adult Spinal Deformity SurgerySALVAGENCT07712666
SALVAGE Trial (Safety And cLinical Value of AutoloGous rEinfusion)
A study testing Cell Saver in people with Adult Spinal Deformity Surgery, run by Mayo Clinic.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Spinal Deformity Surgery
- What is being tested?
- Cell Saver
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Patients with active spinal infection, neoplasm, acute trauma, neuromuscular etiology, syndromic scoliosis, prisoners, and pregnant patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Adult Spinal Deformity Surgery
- Being tested
- Cell Saver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell SaverDevice
Using Cell Saver during surgery
| Study group | Role | What they receive |
|---|---|---|
| Cell Saver | Active comparator | Randomized to utilize cell savor intraoperatively Receives: Device: Cell Saver |
| No Cell Saver | No intervention | Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Adult Spinal Deformity SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony L. Mikula, Mayo Clinic
- Investigators
- Anthony Mikula, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712666
- Sponsor's protocol ID
- 26-004500
- Acronym
- SALVAGE
- Status last verified
- Sep 2026
- First submitted
- 1 Jul 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hassan FM, Sardar ZM, Lenke LG, Mohanty S, Passias PG, Klineberg EO, Lafage V, Smith JS, Hamilton DK, Gum JL, Lafage R, Mullin J, Kelly MP, Diebo BG, Buell TJ, Kim HJ, Kebaish K, Eastlack R, Daniels AH, Mundis G Jr, Protopsaltis TS, Gupta MC, Schwab FJ, Shaffrey CI, Ames CP, Bess S. Association between cell saver transfusion to estimated blood loss ratio and risk of pulmonary embolism after adult spinal deformity surgery. J Neurosurg Spine. 2026 Jan 16;44(4):564-574. doi: 10.3171/2025.8.SPINE25583.
PubMed 41569673Mohanty S, Sardar ZM, Hassan FM, Reyes J, Coury JR, Lombardi JM, Lehman RA, Lenke LG. High Cell Saver Autotransfusion is Associated With Perioperative Medical Complications in Adult Spinal Deformity Patients. Spine (Phila Pa 1976). 2023 Sep 1;48(17):1234-1244. doi: 10.1097/BRS.0000000000004743. Epub 2023 Jun 7.
PubMed 37280746Chung YS, Kim HR, Kang H, Ryu C, Park B, Hong J. Fragility of Red Blood Cells Collected Under Different Conditions With a Cell Saver Device. J Cardiothorac Vasc Anesth. 2019 May;33(5):1224-1229. doi: 10.1053/j.jvca.2018.11.019. Epub 2018 Nov 16.
PubMed 30655204Gregoretti S. Suction-induced hemolysis at various vacuum pressures: implications for intraoperative blood salvage. Transfusion. 1996 Jan;36(1):57-60. doi: 10.1046/j.1537-2995.1996.36196190516.x.
PubMed 8607155Sullivan IJ, Faulds JN. Assessment of intra-operative cell salvage haemolysis in the obstetric and orthopaedic clinical setting, in comparison with allogeneic blood. Transfus Med. 2014 Oct;24(5):280-5. doi: 10.1111/tme.12147. Epub 2014 Sep 3.
PubMed 25185996Liao X, Du K, Zhang J, Meng W, Zuo S, Huang Q, Wang H, Gou D. Red blood cells are damaged by intraoperative blood salvage via Ca2+-dependent and -independent mechanisms. Life Sci. 2019 Jun 15;227:114-121. doi: 10.1016/j.lfs.2019.03.036. Epub 2019 Mar 16.
PubMed 30890406Falsetto A, Roffey DM, Jabri H, Kingwell SP, Stratton A, Phan P, Wai EK. Allogeneic blood transfusions and infection risk in lumbar spine surgery: An American College of Surgeons National Surgery Quality Improvement Program Study. Transfusion. 2022 May;62(5):1027-1033. doi: 10.1111/trf.16864. Epub 2022 Mar 26.
PubMed 35338708Liang J, Shen J, Chua S, Fan Y, Zhai J, Feng B, Cai S, Li Z, Xue X. Does intraoperative cell salvage system effectively decrease the need for allogeneic transfusions in scoliotic patients undergoing posterior spinal fusion? A prospective randomized study. Eur Spine J. 2015 Feb;24(2):270-5. doi: 10.1007/s00586-014-3282-2. Epub 2014 Mar 30.
PubMed 24682378Stone N, Sardana V, Missiuna P. Indications and Outcomes of Cell Saver in Adolescent Scoliosis Correction Surgery: A Systematic Review. Spine (Phila Pa 1976). 2017 Mar 15;42(6):E363-E370. doi: 10.1097/BRS.0000000000001780.
PubMed 27398896Cheriyan J, Cheriyan T, Dua A, Goldstein JA, Errico TJ, Kumar V. Efficacy of intraoperative cell salvage in spine surgery: a meta-analysis. J Neurosurg Spine. 2020 Apr 3;33(2):261-269. doi: 10.3171/2019.12.SPINE19920. Print 2020 Aug 1.
PubMed 32244219Lloyd TD, Geneen LJ, Bernhardt K, McClune W, Fernquest SJ, Brown T, Doree C, Brunskill SJ, Murphy MF, Palmer AJ. Cell salvage for minimising perioperative allogeneic blood transfusion in adults undergoing elective surgery. Cochrane Database Syst Rev. 2023 Sep 8;9(9):CD001888. doi: 10.1002/14651858.CD001888.pub5.
PubMed 37681564Nayak P, Hostin R, Klineberg EO, Lafage R, Cardona AE, Oreilly BT, Line B, Passias PG, Bess S, Kebaish K, Lenke LG, Shaffrey CI, Daniels AH, Diebo BG, Ames C, Burton D, Lewis S, Eastlack RK, Mundis GM Jr, Nunley P, Hart RA, Mullin J, Hamilton DK, Lafage V, Gupta M, Kelly MP, Protopsaltis TS, Kim HJ, Schwab F, Smith JS, Gum JL; ISSG. Impact of Complications on DRG Assignment for Adult Spinal Deformity Surgery Using the ISSG-AO Classification System. Spine (Phila Pa 1976). 2026 Aug 15;51(16):1163-1170. doi: 10.1097/BRS.0000000000005566. Epub 2025 Nov 12.
PubMed 41222566Wick JB, Blandino A, Smith JS, Line BG, Lafage V, Lafage R, Kim HJ, Passias PG, Gum JL, Kebaish KM, Eastlack RK, Daniels A, Mundis G, Hostin R, Protopsaltis T, Hamilton DK, Kelly MP, Gupta M, Hart RA, Schwab FJ, Burton DC, Ames CP, Lenke LG, Shaffrey CI, Bess S, Klineberg E; International Spine Study Group. The ISSG-AO Complication Intervention Score, but Not Major/Minor Designation, is Correlated With Length of Stay Following Adult Spinal Deformity Surgery. Global Spine J. 2025 Mar;15(2):621-632. doi: 10.1177/21925682231202782. Epub 2023 Sep 19.
PubMed 37725904Klineberg EO, Wick JB, Lafage R, Lafage V, Pellise F, Haddad S, Yilgor C, Nunez-Pereira S, Gupta M, Smith JS, Shaffrey C, Schwab F, Ames C, Bess S, Lewis S, Lenke LG, Berven S; International Spine Study Group. Development and Validation of a Multidomain Surgical Complication Classification System for Adult Spinal Deformity. Spine (Phila Pa 1976). 2021 Feb 15;46(4):E267-E273. doi: 10.1097/BRS.0000000000003766.
PubMed 33156283Ayala M, Nookala V, Fogel J, Fatehi M. Visual estimation of blood loss versus quantitative blood loss for maternal outcomes related to obstetrical hemorrhage. Proc (Bayl Univ Med Cent). 2023 Mar 13;36(3):341-345. doi: 10.1080/08998280.2023.2187248. eCollection 2023.
PubMed 37091754
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07712666
- Acronym / sponsor ID
- SALVAGE / 26-004500
- Conditions
- Adult Spinal Deformity Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell Saver | Active comparator | Device: Cell SaverRandomized to utilize cell savor intraoperatively |
| No Cell Saver | No intervention | –Control Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients with active spinal infection, neoplasm, acute trauma, neuromuscular etiology, syndromic scoliosis, prisoners, and pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell SaverUsing Cell Saver during surgery | Device | Cell Saver |
Primary outcome
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 secondary outcomes
Compare complication rates and other secondary outcomes
Time frame: 2 years
Measure the number of salvaged blood cell units transfused during the hospital stay.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 41569673Hassan FM, Sardar ZM, Lenke LG, Mohanty S, Passias PG, Klineberg EO, Lafage V, Smith JS, Hamilton DK, Gum JL, Lafage R, Mullin J, Kelly MP, Diebo BG, Buell TJ, Kim HJ, Kebaish K, Eastlack R, Daniels AH, Mundis G Jr, Protopsaltis TS, Gupta MC, Schwab FJ, Shaffrey CI, Ames CP, Bess S. Association between cell saver transfusion to estimated blood loss ratio and risk of pulmonary embolism after adult spinal deformity surgery. J Neurosurg Spine. 2026 Jan 16;44(4):564-574. doi: 10.3171/2025.8.SPINE25583.
- Background: PubMed 37280746Mohanty S, Sardar ZM, Hassan FM, Reyes J, Coury JR, Lombardi JM, Lehman RA, Lenke LG. High Cell Saver Autotransfusion is Associated With Perioperative Medical Complications in Adult Spinal Deformity Patients. Spine (Phila Pa 1976). 2023 Sep 1;48(17):1234-1244. doi: 10.1097/BRS.0000000000004743. Epub 2023 Jun 7.
- Background: PubMed 30655204Chung YS, Kim HR, Kang H, Ryu C, Park B, Hong J. Fragility of Red Blood Cells Collected Under Different Conditions With a Cell Saver Device. J Cardiothorac Vasc Anesth. 2019 May;33(5):1224-1229. doi: 10.1053/j.jvca.2018.11.019. Epub 2018 Nov 16.
- Background: PubMed 8607155Gregoretti S. Suction-induced hemolysis at various vacuum pressures: implications for intraoperative blood salvage. Transfusion. 1996 Jan;36(1):57-60. doi: 10.1046/j.1537-2995.1996.36196190516.x.
- Background: PubMed 25185996Sullivan IJ, Faulds JN. Assessment of intra-operative cell salvage haemolysis in the obstetric and orthopaedic clinical setting, in comparison with allogeneic blood. Transfus Med. 2014 Oct;24(5):280-5. doi: 10.1111/tme.12147. Epub 2014 Sep 3.
- Background: PubMed 30890406Liao X, Du K, Zhang J, Meng W, Zuo S, Huang Q, Wang H, Gou D. Red blood cells are damaged by intraoperative blood salvage via Ca2+-dependent and -independent mechanisms. Life Sci. 2019 Jun 15;227:114-121. doi: 10.1016/j.lfs.2019.03.036. Epub 2019 Mar 16.
- Background: PubMed 35338708Falsetto A, Roffey DM, Jabri H, Kingwell SP, Stratton A, Phan P, Wai EK. Allogeneic blood transfusions and infection risk in lumbar spine surgery: An American College of Surgeons National Surgery Quality Improvement Program Study. Transfusion. 2022 May;62(5):1027-1033. doi: 10.1111/trf.16864. Epub 2022 Mar 26.
- Background: PubMed 24682378Liang J, Shen J, Chua S, Fan Y, Zhai J, Feng B, Cai S, Li Z, Xue X. Does intraoperative cell salvage system effectively decrease the need for allogeneic transfusions in scoliotic patients undergoing posterior spinal fusion? A prospective randomized study. Eur Spine J. 2015 Feb;24(2):270-5. doi: 10.1007/s00586-014-3282-2. Epub 2014 Mar 30.
- Background: PubMed 27398896Stone N, Sardana V, Missiuna P. Indications and Outcomes of Cell Saver in Adolescent Scoliosis Correction Surgery: A Systematic Review. Spine (Phila Pa 1976). 2017 Mar 15;42(6):E363-E370. doi: 10.1097/BRS.0000000000001780.
- Background: PubMed 32244219Cheriyan J, Cheriyan T, Dua A, Goldstein JA, Errico TJ, Kumar V. Efficacy of intraoperative cell salvage in spine surgery: a meta-analysis. J Neurosurg Spine. 2020 Apr 3;33(2):261-269. doi: 10.3171/2019.12.SPINE19920. Print 2020 Aug 1.
- Background: PubMed 37681564Lloyd TD, Geneen LJ, Bernhardt K, McClune W, Fernquest SJ, Brown T, Doree C, Brunskill SJ, Murphy MF, Palmer AJ. Cell salvage for minimising perioperative allogeneic blood transfusion in adults undergoing elective surgery. Cochrane Database Syst Rev. 2023 Sep 8;9(9):CD001888. doi: 10.1002/14651858.CD001888.pub5.
- Background: PubMed 41222566Nayak P, Hostin R, Klineberg EO, Lafage R, Cardona AE, Oreilly BT, Line B, Passias PG, Bess S, Kebaish K, Lenke LG, Shaffrey CI, Daniels AH, Diebo BG, Ames C, Burton D, Lewis S, Eastlack RK, Mundis GM Jr, Nunley P, Hart RA, Mullin J, Hamilton DK, Lafage V, Gupta M, Kelly MP, Protopsaltis TS, Kim HJ, Schwab F, Smith JS, Gum JL; ISSG. Impact of Complications on DRG Assignment for Adult Spinal Deformity Surgery Using the ISSG-AO Classification System. Spine (Phila Pa 1976). 2026 Aug 15;51(16):1163-1170. doi: 10.1097/BRS.0000000000005566. Epub 2025 Nov 12.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony Mikula, M.D. principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Cell Saver in people with Adult Spinal Deformity Surgery, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Westendorf (507-284-8167, westendorf.laura@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the impact of intraoperative salvaged red blood cells on resuscitation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07712666, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.