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Efficacy of Preoperative Oral Iron Supplementation in Adolescents Undergoing Scoliosis Surgery

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
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-09-01 至 2028-08-31
关键词:
Activities of Daily LivingAddressAdherenceAdolescentAdultAdverse effectsAffectAnemiaBloodBlood TransfusionCaringChildChildhoodClinicalCognitiveCommunity TrialDataEnsureEpidemiologyErythrocyte TransfusionErythrocytesFemale AdolescentsFerritinFutureGoalsGrowth and Development functionHematologyHemoglobinHemorrhageIdiopathic scoliosisImpaired cognitionImpairmentIncidenceInfectionInstitutionInterventionIronLinkMenstruationMentorsMonitorMuscle functionNeurocognitionNeurocognitiveNeurotransmittersNutritionalOperating RoomsOperative Surgical ProceduresOralOutcomePatient Outcomes AssessmentsPatient-Focused OutcomesPatientsPediatric Surgical ProceduresPerioperativePersonsPhysical CapacityPhysical FunctionPhysiologicalPilot ProjectsPlacebosPopulationPostoperative PeriodPredispositionPreoperative CareProductionProtocols documentationQuality of CareRandomizedRandomized, Controlled TrialsRecoveryRecovery of FunctionRegimenReportingResearchResearch DesignResearch PersonnelRiskRisk FactorsRoleSerumSerum MarkersSignal TransductionSpinal FusionSpine surgerySupplementationSurgical Blood LossTestingTrace ElementsTrainingTransfusionUnited States National Institutes of HealthVulnerable PopulationsWorkadverse outcomeagedcareercognitive capacitydesignearly childhoodefficacy evaluationevidence baseexperiencefollow-upfunctional declinefunctional outcomesfunctional statushigh riskimprovedimproved outcomeiron deficiencyiron supplementationmodifiable riskneurocognitive testpediatric patientspreventscoliosisstandard of caresurgery outcomevulnerable adolescent

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项目摘要 通过拟议的研究和培训计划,PI寻求发展成为一名独立的调查员, 确定有针对性的患者血液管理干预以改善儿科预后的职业目标 外科病人。接受脊柱融合术治疗青少年特发性脊柱侧凸(AIS)的患者准备就绪 从许多这样的干预中受益。脊柱融合术有手术失血过多的风险 围术期红细胞输注,这与这一人群的不良结局有关。这些 患者大多是青春期女性,这是一个更容易患上缺铁和由此导致的贫血的群体 由于月经期间铁丢失而导致的基线,以及在手术期间铁储存受到额外侮辱的人。 然而,在这种情况下,铁的状况不是常规监测的,也没有术前护理的标准。 铁补充剂。铁是一种营养必需的微量元素,不仅对红细胞很重要 生产,但也为肌肉功能和神经递质的合成和信号。因此,治疗 术前缺铁是优化手术前血红蛋白的一个重要目标,减少 输血率和改善患者预后。铁本身,作为贫血的主要原因, 我们的研究小组认为缺乏输血是唯一的危险因素,可以在手术前改变。 此外,补充铁还可以减轻相关的体能和认知能力的损害。 在青春期女性中,即使是轻微的缺铁也是如此。在我们机构进行的一项试点研究发现 36%的AIS患者术前铁缺乏,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一种可改变的风险因素来研究。 在这一脆弱人群中,输血和术后认知和身体能力受损。上一首 在大多数铁状态未知的高危成人外科患者中进行简单铁干预的试验不会得到通知 该方案旨在解决铁缺乏青少年的护理问题,并不是为了解决术后功能结果问题。我们 因此将进行一项单中心随机对照试验,在该试验中,铁缺乏的AIS患者被确定为 使用基于生理的血清标记物的患者将随机分为3个月的术前每日口服方案 铁或安慰剂,以验证术前补铁可降低红血率的假说 细胞输注,2)与术前相比,术后神经认知能力改善,3)改善 患者-报告康复期间的身体功能。我们的结果最终将改善这方面的结果 并为减少患者血液管理方法提供证据 在最近严重的血液短缺情况下进行输血。
英文摘要
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.
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