2024-514857-31-00招募中2 期
Pooled human plasma vs. Crystalloid in the fluid management of children undergoing instrumented spinal fusion for scoliosis. A double-blind, randomized clinical trial.
HUS-Yhtymae2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年11月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Primary outcome is the intraoperative blood loss (blood loss in mL after wound closure).
研究概览
简要总结
To quantify the efficacy of OCTAPLAS infusion to reduce intraoperative blood loss compared with PLASMALYTE in subjects undergoing PSF for scoliosis.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Scoliosis patients (aged 10 to 21 years of age) undergoing posterior spinal fusion for adolescent idiopathic scoliosis or neuromuscular scoliosis (>45 degrees) using pedicle screw technique.
排除标准
- •Coagulation disorder, smoking, unwilling to consent, vertebral column resection, need for anteroposterior surgery and body mass index over 40.
结局指标
主要结局
Primary outcome is the intraoperative blood loss (blood loss in mL after wound closure).
Primary outcome is the intraoperative blood loss (blood loss in mL after wound closure).
次要结局
- Secondary outcomes include need for allogenic red blood cell infusion (percentage of patients at hospital release, health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain (48-hour opioid consumption, pain visual analogue score), operative time (hours), drain output (mL), hidden blood loss (mL), hospital stay, and complications (skin reactions, TRALI, deep surgical site infection).
研究者
Clinical Trial Unit (CTU)
Scientific
HUS-Yhtymae
研究点 (2)
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