Efficacy of Preoperative Oral Iron Supplementation in Adolescents Undergoing Scoliosis Surgery
Efficacy of Preoperative Oral Iron Supplementation in Adolescents Undergoing Scoliosis Surgery
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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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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