SALVAGE Trial (Safety And cLinical Value of AutoloGous rEinfusion) (SALVAGE)
14. juli 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
146
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Laura Westendorf
- Telefonnummer: 507-284-8167
- E-mail: westendorf.laura@mayo.edu
Undersøgelse Kontakt Backup
- Navn: Justice Story
- Telefonnummer: 507-422-5528
- E-mail: story.justice@mayo.edu
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Cell Saver
Randomized to utilize cell savor intraoperatively
|
Using Cell Saver during surgery
|
|
Ingen indgriben: No Cell Saver
Control Arm
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Measure the impact of intraoperative salvaged red blood cells on resuscitation
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Compare complication rates and other secondary outcomes
Tidsramme: 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.
Tidsramme: 2 years
|
Measure the number of salvaged blood cell units transfused during the hospital stay.
|
2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Anthony Mikula, M.D., Mayo Clinic
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- Mohanty 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.
- Chung 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.
- Gregoretti 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.
- Sullivan 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.
- Liao 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.
- Falsetto 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.
- Liang 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.
- Stone 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.
- Cheriyan 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.
- Lloyd 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.
- Nayak P, Hostin R, Klineberg EO, Lafage R, Lizardi AC, Oreilly BT, Line B, Passias PG, Bess S, Kebaish K, Lenke LG, Shaffrey CI, Daniels AH, Diebo B, Ames C, Burton D, Lewis S, Eastlack RK, Mundis GM, Nunley P, Hart RA, Mullin J, Hamilton DK, Lafage V, Gupta M, Kelly M, 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). 2025 Nov 12. doi: 10.1097/BRS.0000000000005566. Online ahead of print.
- Wick 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.
- Klineberg 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.
- Ayala 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.
- Kafka P, Jezek J, Svec J, Odstrcilova I, Skala-Rosenbaum J. Spine surgery and major blood loss: how accurate is suction canister estimation? Eur Spine J. 2026 Apr;35(4):2089-2094. doi: 10.1007/s00586-025-09361-3. Epub 2025 Sep 13.
- Mikula AL, Eastlack RK, Turner JD, Mullin JP, Scheer JK, Lafage R, Lafage V, Kebaish KM, Klineberg EO, Mundis GM Jr, Daniels AH, Lewis SJ, Passias PG, Protopsaltis TS, Uribe JS, Gupta MC, Kim HJ, Kelly MP, Smith JS, Lenke LG, Shaffrey CI, Bess S, Ames CP. Incidence of de novo sacroiliac joint pain following adult spinal deformity surgery with pelvic fixation. J Neurosurg Spine. 2025 Dec 12;44(3):449-456. doi: 10.3171/2025.7.SPINE25454.
- Kurland DB, Frempong-Boadu A, Lau D. What's the harm? Evaluating complications associated with salvaged red blood cell transfusion in spinal deformity surgery: a nonrandomized controlled trial. J Neurosurg Spine. 2025 Aug 1;43(5):569-576. doi: 10.3171/2025.5.SPINE25348. Print 2025 Nov 1.
- Kurland DB, Alber D, Smith A, Ahmed S, Orringer D, Frempong-Boadu A, Lau D. What Are We Transfusing? Evaluating the Quality and Clinical Utility of Intraoperatively Salvaged Red Blood Cells in Spinal Deformity Surgery: A Nonrandomized Controlled Trial. Neurosurgery. 2024 Nov 1;95(5):976-985. doi: 10.1227/neu.0000000000003131. Epub 2024 Aug 1.
- Jain H, Ahluwalia R, Sarikonda A, Sundrani S, Zakieh O, Lyons AT, Krishna S, Osama TA, Montogomery A, Navid W, Zeoli T, Younus I, Jonzzon S, Chanbour H, Lugo-Pico JG, Abtahi AM, Stephens BF, Zuckerman SL. Cell Saver in Adult Spinal Deformity Surgery: Helping or Hurting? Neurosurgery. 2026 Jan 27. doi: 10.1227/neu.0000000000003909. Online ahead of print.
- Brewster DC, Ambrosino JJ, Darling RC, Davison JK, Warnock DF, May AR, Abbott WM. Intraoperative autotransfusion in major vascular surgery. Am J Surg. 1979 Apr;137(4):507-13. doi: 10.1016/0002-9610(79)90122-3.
- Lakomkin N, Stannard B, Fogelson JL, Mikula AL, Lenke LG, Zuckerman SL. Comparison of surgical invasiveness and morbidity of adult spinal deformity surgery to other major operations. Spine J. 2021 Nov;21(11):1784-1792. doi: 10.1016/j.spinee.2021.07.013. Epub 2021 Jul 29.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. august 2028
Studieafslutning (Anslået)
1. august 2029
Datoer for studieregistrering
Først indsendt
1. juli 2026
Først indsendt, der opfyldte QC-kriterier
14. juli 2026
Først opslået (Faktiske)
17. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26-004500
Plan for individuelle deltagerdata (IPD)
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