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RecruitingNCT07661589Updated Jun 22, 2026

Blood Transfusion Risk Factors and Cell Saver Impact in Pediatric Scoliosis Surgery

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

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
Up to 17 Years
Sex
All
01

Study 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.

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Conditions studied

  • Scoliosis; Spinal Fusion; Blood Transfusion; Operative Blood Loss

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Keywords

  • Pediatric scoliosis, Cell Saver, Homologous blood transfusion, Risk factors, Spine surgery, Posterior spinal fusion
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Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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)

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Procedure: posterior Instrumented Spinal Fusion · Device: Intraoperative Cell Saver Autologous Reinfusion

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.

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What researchers measure

Primary outcomes

  1. 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).

Secondary outcomes

  1. Blood conservation rate achieved by intraoperative autologous blood salvage

    Time frame: Intraoperative period (from skin incision to skin closure)

  2. 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).

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Study locations

1 of 1 sites recruiting
  • Bechir Hamza Children Hospital
    Tunis, Tunisia
    Recruiting
07

Registry details

Key details

Study ID
NCT07661589
Lead sponsor
Mehdi Trifa
Responsible party
Mehdi Trifa (Professor, Tunis University) — Sponsor-investigator
First posted
Jun 22, 2026
Start date
Apr 1, 2023
Primary completion
Mar 2, 2026
Completion
Dec 31, 2026 (estimated)
Last update
Jun 22, 2026

Study contacts

Rym Karaborni
Contact
karabornirym@gmail.com
0021651870732

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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