[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641852":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":11,"studyPopulation":23,"armGroups":24,"interventions":31,"overallOfficials":11,"centralContacts":42,"locations":48,"responsibleParty":66,"collaborators":11,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":11,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":11,"maxAge":78,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":11,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Tunis University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients requiring perioperative homologous Red Blood Cell (RBC) transfusion",null,": From the start of surgery (anesthesia induction) up to postoperative day 3 (Day 0 to Day 3).",[14,17],{"measure":15,"description":11,"timeFrame":16},"Blood conservation rate achieved by intraoperative autologous blood salvage","Intraoperative period (from skin incision to skin closure)",{"measure":18,"description":11,"timeFrame":19},"Total volume of homologous Red Blood Cells (RBC) transfused.","From the start of surgery up to postoperative day 3 (Day 0 to Day 3).",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":21,"timePerspective":22,"maskingInfo":11},"COHORT","RETROSPECTIVE","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)",[25],{"label":26,"type":11,"description":27,"interventionNames":28},"Pediatric Scoliosis Cohort","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",[29,30],"Procedure: posterior Instrumented Spinal Fusion","Device: Intraoperative Cell Saver Autologous Reinfusion",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"PROCEDURE","posterior Instrumented Spinal Fusion","Standard surgical correction of scoliosis via a posterior approach with spinal instrumentation and arthrodesis, performed under general anesthesia",[26],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"DEVICE","Intraoperative Cell Saver Autologous Reinfusion","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.",[26],[43],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},"Rym Karaborni","CONTACT","0021651870732","karabornirym@gmail.com",[49],{"facility":50,"status":51,"city":52,"state":11,"zip":11,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Bechir Hamza Children Hospital","RECRUITING","Tunis","Tunisia","TN",{"type":56,"coordinates":57},"Point",[58,59],10.16579,36.81897,{"lat":59,"lon":58},[62],{"name":63,"role":45,"phone":64,"phoneExt":11,"email":65},"Mehdi Trifa, Professor","+21698135697","mehdi.trifa@gmail.com",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Mehdi Trifa","Professor","100641852","blood-transfusion-risk-factors-and-cell-saver-impact-in-pediatric-scoliosis-surgery-100641852",false,"NCT07661589","Blood Transfusion Risk Factors and Cell Saver Impact in Pediatric Scoliosis Surgery","Risk Factors for Homologous Blood Transfusion and Impact of Cell Saver Use in Pediatric Scoliosis Surgery: A Retrospective Monocentric Study","Inclusion Criteria:\n\n* Patient aged under 18 years (\\\u003C 18 years old).\n* Programmed surgical correction for scoliosis (including idiopathic, neuromuscular, and congenital etiologies).\n* Instrumented surgery involving posterior spinal arthrodesis.\n\nExclusion Criteria:\n\n* Revision spine surgeries.\n* Known constitutional hemostasis disorders.\n* Non-orthopedic spine surgeries.\n* Missing core clinical or transfusion data.","ALL","17 Years",{"count":80,"type":81},200,"ESTIMATED","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.",[85],"Scoliosis; Spinal Fusion; Blood Transfusion; Operative Blood Loss",[87],"Pediatric scoliosis, Cell Saver, Homologous blood transfusion, Risk factors, Spine surgery, Posterior spinal fusion","2026-06-16",{"date":90,"type":91},"2026-06-22","ACTUAL",{"date":93,"type":91},"2023-04-01",{"date":95,"type":81},"2026-12-31",{"name":68,"class":6},1]