跳至主要内容
临床试验/NCT07661589
NCT07661589招募中不适用

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

Mehdi Trifa1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Proportion of patients requiring perioperative homologous Red Blood Cell (RBC) transfusion

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

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

干预措施: posterior Instrumented Spinal Fusion (Procedure)

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

干预措施: Intraoperative Cell Saver Autologous Reinfusion (Device)

结局指标

主要结局

Proportion of patients requiring perioperative homologous Red Blood Cell (RBC) transfusion

时间窗: : From the start of surgery (anesthesia induction) up to postoperative day 3 (Day 0 to Day 3).

次要结局

  • Blood conservation rate achieved by intraoperative autologous blood salvage(Intraoperative 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).)

研究者

发起方
Mehdi Trifa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mehdi Trifa

Professor

Tunis University

研究点 (1)

Loading locations...

相似试验