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.

项目概要通过拟议的研究和培训计划，PI 力求发展成为一名独立调查员，确定有针对性的患者血液管理干预措施以改善儿科治疗结果的职业目标手术患者。接受脊柱融合手术治疗青少年特发性脊柱侧凸 (AIS) 的患者已做好准备从许多此类干预措施中受益。脊柱融合术存在手术大量失血的风险围手术期红细胞输注与该人群的不良后果相关。这些患者大多是青春期女性，这一群体更容易缺铁并由此导致贫血。由于月经期间铁流失而造成的基线，以及在手术期间铁储存受到额外损害的人。然而，在这种情况下，铁的状态并未得到常规监测，并且术前也没有护理标准。补铁。铁是一种营养必需的微量元素，不仅对红细胞很重要生产，还用于肌肉功能和神经递质合成和信号传导。因此，治疗术前缺铁是术前优化血红蛋白、减少术前缺铁的重要目标。输血率，并改善患者的治疗效果。铁本身是贫血的主要原因我们小组将缺乏症确定为唯一可在术前改变的输血危险因素。此外，铁补充剂被证明可以减轻与身体和认知能力相关的损害。青春期女性甚至有轻微的缺铁症状。在我们机构进行的一项试点研究确定 36% 的 AIS 患者术前缺铁，术前铁状态与铁高度相关手术恢复期间的状态。因此，我们计划将缺铁作为可改变的风险因素进行研究输血以及该弱势群体术后认知和身体能力受损。以前的对高危成人手术患者（大多数铁状态未知）进行短暂铁干预的试验并未提供信息是针对缺铁青少年的护理，并非旨在解决术后功能结果。我们因此，将进行一项单中心随机对照试验，其中确定了缺铁的 AIS 患者使用基于生理学的血清标记物将被随机分配到术前 3 个月的每日口服治疗方案铁或安慰剂，检验术前补铁 1) 降低红细胞率的假设细胞输注，2) 与术前基线相比改善术后神经认知，3) 改善患者报告康复期间的身体机能。我们的结果最终将改善这方面的成果弱势儿科人群，并为患者血液管理方法提供证据，以减少在最近严重的血液短缺中进行输血。