SALVAGE Trial (Safety And cLinical Value of AutoloGous rEinfusion)

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

Overview

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:

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.

Interventions

• Device Cell Saver
  Using Cell Saver during surgery

Primary outcome measures

• Measure the impact of intraoperative salvaged red blood cells on resuscitation [Time frame: 2 years]

Secondary outcome measures (2)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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 PMID 41569673
• 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. PMID 37280746
• 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. PMID 30655204
• 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. PMID 8607155
• 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. PMID 25185996
• 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. PMID 30890406
• 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. PMID 35338708
• 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. PMID 24682378

Identifiers

NCT: NCT07712666 · 26-004500

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗