PDF(Pubmed)
Abstract：
Postoperative anaemia is prevalent in adult spinal deformity (ASD) surgery in association with unfavourable outcomes. Ferric derisomaltose, a novel iron supplement, offers a promising solution in rapidly treating postoperative anaemia. However, the clinical evidence of its effect on patients receiving spinal surgery remains inadequate. This randomised controlled trial aims to evaluate the safety and efficacy of ferric derisomaltose on postoperative anaemia in ASD patients.
This single-centre, phase 4, randomised controlled trial will be conducted at Department of Orthopaedics at Peking Union Medical College Hospital and aims to recruit adult patients who received ASD surgery with postoperative anaemia. Eligible participants will be randomly assigned to receive ferric derisomaltose infusion or oral ferrous succinate. The primary outcome is the change in haemoglobin concentrations from postoperative days 1-14. Secondary outcomes include changes in iron parameters, reticulocyte parameters, postoperative complications, allogeneic red blood cell infusion rates, length of hospital stay, functional assessment and quality-of-life evaluation.
This study has been approved by the Research Ethics Committee of Peking Union Medical College Hospital and registered at ClinicalTrials.gov. Informed consent will be obtained from all participants prior to enrolment and the study will be conducted in accordance with the principles of the Declaration of Helsinki. The results of this study are expected to be disseminated through peer-reviewed journals and academic conferences.
NCT05714007.
This single-centre, phase 4, randomised controlled trial will be conducted at Department of Orthopaedics at Peking Union Medical College Hospital and aims to recruit adult patients who received ASD surgery with postoperative anaemia. Eligible participants will be randomly assigned to receive ferric derisomaltose infusion or oral ferrous succinate. The primary outcome is the change in haemoglobin concentrations from postoperative days 1-14. Secondary outcomes include changes in iron parameters, reticulocyte parameters, postoperative complications, allogeneic red blood cell infusion rates, length of hospital stay, functional assessment and quality-of-life evaluation.
This study has been approved by the Research Ethics Committee of Peking Union Medical College Hospital and registered at ClinicalTrials.gov. Informed consent will be obtained from all participants prior to enrolment and the study will be conducted in accordance with the principles of the Declaration of Helsinki. The results of this study are expected to be disseminated through peer-reviewed journals and academic conferences.
NCT05714007.
摘要：
背景：术后贫血在成人脊柱畸形（ASD）手术中普遍存在，与不良结局相关。地异麦芽糖铁,一种新的铁补充剂，为快速治疗术后贫血提供了一个有希望的解决方案。然而,其对脊柱手术患者的影响的临床证据仍然不足。这项随机对照试验旨在评估黑铁对ASD患者术后贫血的安全性和有效性。
方法：这种单中心，第4阶段，随机对照试验将在北京协和医院骨科进行，旨在招募接受ASD手术后贫血的成年患者。符合条件的参与者将被随机分配接受铁脱糖麦芽糖输注或口服琥珀酸亚铁。主要结果是术后第1-14天血红蛋白浓度的变化。次要结果包括铁参数的变化，网织红细胞参数,术后并发症,同种异体红细胞输注率，住院时间,功能评估和生活质量评估。
背景：本研究已获北京协和医院研究伦理委员会批准，并在ClinicalTrials.gov注册。注册前将获得所有参与者的知情同意，研究将根据《赫尔辛基宣言》的原则进行。这项研究的结果预计将通过同行评审的期刊和学术会议传播。
背景：NCT05714007。
方法：这种单中心，第4阶段，随机对照试验将在北京协和医院骨科进行，旨在招募接受ASD手术后贫血的成年患者。符合条件的参与者将被随机分配接受铁脱糖麦芽糖输注或口服琥珀酸亚铁。主要结果是术后第1-14天血红蛋白浓度的变化。次要结果包括铁参数的变化，网织红细胞参数,术后并发症,同种异体红细胞输注率，住院时间,功能评估和生活质量评估。
背景：本研究已获北京协和医院研究伦理委员会批准，并在ClinicalTrials.gov注册。注册前将获得所有参与者的知情同意，研究将根据《赫尔辛基宣言》的原则进行。这项研究的结果预计将通过同行评审的期刊和学术会议传播。
背景：NCT05714007。
