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NCT Number: NCT07661589

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

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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Key information

Conditions

Scoliosis; Spinal Fusion; Blood Transfusion; Operative Blood Loss Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bechir Hamza Children Hospital

Tunis, Tunisia

Location status: Recruiting

Location contact

Mehdi Trifa, Professor

CONTACT

[email protected]

+21698135697

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

posterior Instrumented Spinal Fusion

Procedure

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.

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).

Study contacts

Contact information is provided by the study sponsor or research team.

Rym Karaborni

CONTACT

[email protected]

0021651870732

Sponsors and collaborators

Lead sponsor

Mehdi Trifa

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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