Efficacy of Preoperative Oral Iron Supplementation in Adolescents Undergoing Scoliosis Surgery

术前口服铁补充剂对接受脊柱侧凸手术的青少年的疗效

基本信息

批准号：
10785834
负责人：
Lisa Danielle Eisler
金额：
$ 19.36万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-01 至 2028-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10785834
关键词：
Activities of Daily Living Address Adherence Adolescent Adult Adverse effects Affect Anemia Blood Blood Transfusion Caring Child Childhood Clinical Cognitive Community Trial Data Ensure Epidemiology Erythrocyte Transfusion Erythrocytes Female Adolescents Ferritin Future Goals Growth and Development function Hematology Hemoglobin Hemorrhage Idiopathic scoliosis Impaired cognition Impairment Incidence Infection Institution Intervention Iron Link Menstruation Mentors Monitor Muscle function Neurocognition Neurocognitive Neurotransmitters Nutritional Operating Rooms Operative Surgical Procedures Oral Outcome Patient Outcomes Assessments Patient-Focused Outcomes Patients Pediatric Surgical Procedures Perioperative Persons Physical Capacity Physical Function Physiological Pilot Projects Placebos Population Postoperative Period Predisposition Preoperative Care Production Protocols documentation Quality of Care Randomized Randomized, Controlled Trials Recovery Recovery of Function Regimen Reporting Research Research Design Research Personnel Risk Risk Factors Role Serum Serum Markers Signal Transduction Spinal Fusion Spine surgery Supplementation Surgical Blood Loss Testing Trace Elements Training Transfusion United States National Institutes of Health Vulnerable Populations Work adverse outcome aged career cognitive capacity design early childhood efficacy evaluation evidence base experience follow-up functional decline functional outcomes functional status high risk improved improved outcome iron deficiency iron supplementation modifiable risk neurocognitive test pediatric patients prevent scoliosis standard of care surgery outcome vulnerable adolescent

项目摘要

Project Summary Through the proposed research and training plan, the PI seeks to develop into an independent investigator with the career goal of identifying targeted patient blood management interventions to improve outcomes in pediatric surgical patients. Patients undergoing spinal fusion surgery for Adolescent Idiopathic Scoliosis (AIS) are poised to benefit from many of these interventions. Spinal fusion carries a risk of large surgical blood losses and perioperative red blood cell transfusion, which are associated with adverse outcomes in this population. These patients are mostly adolescent females, a group more susceptible to iron deficiency and resulting anemia at baseline due to iron losses with menses, and who suffer an additional insult to iron stores during surgery. Nevertheless, iron status is not routinely monitored in this setting and there is no standard of care for preoperative iron supplementation. Iron is a nutritionally essential trace element important not only for red blood cell production, but also for muscle function and neurotransmitter synthesis and signaling. Therefore, the treatment of preoperative iron deficiency is an important target for optimizing hemoglobin prior to surgery, reducing transfusion rates, and improving patient outcomes. On its own and as the primary cause of anemia, iron deficiency was identified by our group as the only risk factor for transfusion which is modifiable preoperatively. In addition, iron supplementation is shown to alleviate impairments of physical and cognitive capacity associated with even mild forms of iron deficiency in adolescent females. A pilot study conducted at our institution identified iron deficiency in 36% of AIS patients prior to surgery, with preoperative iron status highly correlated with iron status during surgical recovery. Consequently, we plan to examine iron deficiency as a modifiable risk factor for transfusion and impaired postoperative cognitive and physical capacity in this vulnerable population. Previous trials of brief iron interventions in high-risk adult surgical patients, mostly with unknown iron status, do not inform the care of iron deficient adolescents and were not designed to address postoperative functional outcomes. We will therefore perform a single-center randomized controlled trial in which iron-deficient AIS patients identified using physiologically-based serum markers will be randomized to a 3-month preoperative regimen of daily oral iron or placebo, to test the hypotheses that preoperative iron supplementation 1) reduces the rate of red blood cell transfusion, 2) improves postoperative neurocognition compared to a preoperative baseline, and 3) improves patient-reported physical functioning during recovery. Our results will ultimately improve outcomes in this vulnerable pediatric population and provide evidence for patient blood management approaches to reduce transfusions amid recent severe blood shortages.

项目摘要通过拟议的研究和培训计划，PI试图与确定有针对性的患者血液管理干预措施以改善小儿预后的职业目标外科患者。接受青少年特发性脊柱侧弯（AIS）的脊柱融合手术的患者已保持从其中许多干预措施中受益。脊柱融合会有大量手术失血的风险，并且围手术期的红细胞输血与该人群的不良结果有关。这些患者主要是青春期的女性，这是一个更容易患上铁缺乏症的人，导致的贫血基线是由于带有月经的铁损失而导致的，他们在手术期间对铁店造成了额外的侮辱。尽管如此，在这种情况下，没有常规监控铁的状态，并且没有术前的护理标准补充铁。铁是营养上必不可少的痕量元素，不仅对红血细胞很重要生产，还用于肌肉功能和神经递质的合成和信号传导。因此，治疗术前铁缺乏症是在手术前优化血红蛋白的重要目标输血率和改善患者预后。熨斗本身也是贫血的主要原因我们的小组将缺陷确定为术前可修改的输血唯一风险因素。此外，补充铁可减轻与身体和认知能力相关的损害青春期女性中甚至有轻度的铁缺乏症。在我们机构确定的一项试点研究手术前36％的AIS患者的铁缺乏症，术前铁状态与铁高度相关手术恢复期间的状态。因此，我们计划将铁缺乏症视为可修改的风险因素在这个脆弱人群中，输血和术后认知和身体能力受损。以前的高危成人手术患者的短暂铁干预措施的试验，主要是铁状态未知的试验护理不足的青少年，并非旨在解决术后功能结果。我们因此，将执行单中心随机对照试验，其中鉴定出铁缺陷的AIS患者使用基于生理的血清标记将被随机分为每日口服的3个月术前疗法铁或安慰剂，以测试术前补充铁的假设1）与术前基线相比，细胞输血2）改善术后神经认知，3）改善康复过程中患者报告的身体功能。我们的结果最终将改善这一点脆弱的儿科人群，并为患者血液管理方法提供了减少的证据在最近严重的血液短缺的情况下，输血。