An observational study in Scoliosis; Spinal Fusion; Blood Transfusion; Operative Blood Loss, sponsored by Mehdi Trifa. Recruiting at 1 site in Tunisia. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Mehdi Trifa · Observational
Spine surgery for scoliosis correction in pediatric patients is a major procedure associated with a high risk of perioperative blood loss. Homologous blood transfusion carries inherent risks, including immunological reactions, infections, and increased healthcare costs. Identifying high-risk patients is crucial to optimize blood conservation strategies. This retrospective study aims to identify preoperative and intraoperative risk factors associated with homologous red blood cell (RBC) transfusion and to evaluate the quantitative impact of Cell Saver volume reinfusion on reducing homologous transfusion requirements.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
This study's planned enrollment of 200 is above the median of 84 across 256 observational studies indexed under Scoliosis.
Browse Scoliosis studies →This is the only study on the registry with Mehdi Trifa as lead sponsor.
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The study population consists of pediatric patients under 18 years of age who underwent major orthopedic spine surgery for scoliosis correction at a single specialized tertiary center. The cohort includes individuals with various scoliosis etiologies-such as idiopathic, neuromuscular, and congenital scoliosis-who required instrumented posterior spinal arthrodesis. Patients are selected from the institutional surgical registry over a continuous 3-year period (from April 2023 to March 2026)
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Exclusion Criteria:
Pediatric patients under 18 years old who underwent posterior instrumented spinal fusion for scoliosis correction (idiopathic, neuromuscular, or congenital) between April 2023 and March 2026. This single cohort is evaluated retrospectively to identify risk factors for homologous blood transfusion and to assess the impact of intraoperative Cell Saver use
Procedure: posterior Instrumented Spinal Fusion · Device: Intraoperative Cell Saver Autologous Reinfusion
Standard surgical correction of scoliosis via a posterior approach with spinal instrumentation and arthrodesis, performed under general anesthesia
Use of an intraoperative autologous blood salvage device (Cell Saver) during spine surgery. Collected blood is washed, filtered, and reinfused to the patient peroperatively to reduce the need for homologous blood transfusion.
Proportion of patients requiring perioperative homologous Red Blood Cell (RBC) transfusion
Time frame: : From the start of surgery (anesthesia induction) up to postoperative day 3 (Day 0 to Day 3).
Blood conservation rate achieved by intraoperative autologous blood salvage
Time frame: Intraoperative period (from skin incision to skin closure)
Total volume of homologous Red Blood Cells (RBC) transfused.
Time frame: From the start of surgery up to postoperative day 3 (Day 0 to Day 3).
Ran from Apr 2023 to primary completion in Mar 2026, 35 months.
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