Health Trials

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

ConditionScoliosis; Spinal Fusion; Blood Transfusion; Operative Blood Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorMehdi Trifa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Revision spine surgeries.

Known constitutional hemostasis disorders.

Non-orthopedic spine surgeries.

Missing core clinical or transfusion data.

Trial 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)

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • posterior Instrumented Spinal Fusion

    Procedure/Surgery

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

  • Intraoperative Cell Saver Autologous Reinfusion

    Device

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Pediatric Scoliosis Cohort2 interventions

Trial outcomes

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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mehdi Trifa

Lead sponsor

Tunis University

Sponsor institution

Source ClinicalTrials.gov
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