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

• 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
• 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

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寻求发展成为独立的研究者， 职业目标是确定有针对性的患者血液管理干预措施，以改善儿科患者的结局。 手术病人青少年特发性脊柱侧凸（AIS）患者接受脊柱融合手术 从这些干预措施中获益。脊柱融合术有大量手术失血的风险， 围手术期红细胞输注与该人群的不良结局相关。这些 患者大多是青春期女性，这一群体更容易缺铁并导致贫血， 由于月经铁损失的基线，以及在手术期间遭受额外的铁储存损伤的患者。 然而，在这种情况下，铁的状态并没有常规监测，也没有术前护理标准。 补充铁。铁是一种重要的微量营养元素，不仅对红细胞 生产，但也为肌肉功能和神经递质的合成和信号。因此，治疗 术前缺铁是术前优化血红蛋白的重要目标， 输血率和改善患者预后。作为贫血的主要原因，铁 我们的小组确定缺乏是输血的唯一危险因素，这是术前可改变的。 此外，铁补充剂被证明可以减轻与铁缺乏相关的身体和认知能力的损害。 即使是轻度缺铁的青少年女性。在我们机构进行的一项试点研究发现， 术前36%的AIS患者存在铁缺乏，术前铁状态与铁水平高度相关。 手术恢复期间的状态。因此，我们计划将缺铁作为一个可改变的风险因素， 输血和术后认知和身体能力受损。先前 在高危成人手术患者中进行的简短铁干预试验，大多数患者的铁状态未知， 缺铁青少年的护理，并不旨在解决术后功能结局。我们 因此，将进行一项单中心随机对照试验，其中确定缺铁AIS患者 使用生理学基础的血清标志物的患者将被随机分配至3个月的术前方案， 铁或安慰剂，以检验以下假设：1）术前补铁可降低红细胞比率， 细胞输注，2）与术前基线相比，改善术后神经认知，以及3）改善 恢复期间患者报告的身体功能。我们的研究结果将最终改善这方面的结果。 为患者血液管理方法提供证据， 在最近严重的血液短缺中输血。