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

June 16, 2026 updated by: Mehdi Trifa

Risk Factors for Homologous Blood Transfusion and Impact of Cell Saver Use in Pediatric Scoliosis Surgery: A Retrospective Monocentric Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Tunisia
      • Tunis, Tunisia
        • Recruiting
        • Bechir Hamza Children Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Standard surgical correction of scoliosis via a posterior approach with spinal instrumentation and arthrodesis, performed under general anesthesia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
: From the start of surgery (anesthesia induction) up to postoperative day 3 (Day 0 to Day 3).

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood conservation rate achieved by intraoperative autologous blood salvage
Time Frame: Intraoperative period (from skin incision to skin closure)
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).
From the start of surgery up to postoperative day 3 (Day 0 to Day 3).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mehdi Trifa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

March 2, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26/2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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