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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07661589
Enrollment
200
Registered
2026-06-22
Start date
2023-04-01
Completion date
2026-12-31
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis; Spinal Fusion; Blood Transfusion; Operative Blood Loss

Keywords

Pediatric scoliosis, Cell Saver, Homologous blood transfusion, Risk factors, Spine surgery, Posterior spinal fusion

Brief summary

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.

Interventions

PROCEDUREposterior Instrumented Spinal Fusion

Standard surgical correction of scoliosis via a posterior approach with spinal instrumentation and arthrodesis, performed under general anesthesia

DEVICEIntraoperative 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.

Sponsors

Mehdi Trifa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

Inclusion criteria

* Patient aged under 18 years (\< 18 years old). * Programmed surgical correction for scoliosis (including idiopathic, neuromuscular, and congenital etiologies). * Instrumented surgery involving posterior spinal arthrodesis.

Exclusion criteria

* Revision spine surgeries. * Known constitutional hemostasis disorders. * Non-orthopedic spine surgeries. * Missing core clinical or transfusion data.

Design outcomes

Primary

MeasureTime frame
Proportion of patients requiring perioperative homologous Red Blood Cell (RBC) transfusion: From the start of surgery (anesthesia induction) up to postoperative day 3 (Day 0 to Day 3).

Secondary

MeasureTime frame
Blood conservation rate achieved by intraoperative autologous blood salvageIntraoperative period (from skin incision to skin closure)
Total volume of homologous Red Blood Cells (RBC) transfused.From the start of surgery up to postoperative day 3 (Day 0 to Day 3).

Countries

Tunisia

Contacts

CONTACTRym Karaborni
karabornirym@gmail.com0021651870732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026