Orthopaedics & Rehabilitation, Oregon Health & Science University, Portland, Oregon, USA.
Biomedical Engineering, Oregon Health & Science University, Portland, Oregon, USA.
BMJ Open. 2023 Mar 21;13(3):e069070. doi: 10.1136/bmjopen-2022-069070.
Orthopaedic trauma and fracture care commonly cause perioperative anaemia and associated functional iron deficiency due to a systemic inflammatory state. Modern, strict transfusion thresholds leave many patients anaemic; managing this perioperative anaemia is an opportunity to impact outcomes in orthopaedic trauma surgery. The primary outcome of this pilot study is feasibility for a large randomised controlled trial (RCT) to evaluate intravenous iron therapy (IVIT) to improve patient well-being following orthopaedic injury. Measurements will include rate of participant enrolment, screening failure, follow-up, missing data, adverse events and protocol deviation.
This single-centre, pilot, double-blind RCT investigates the use of IVIT for acute blood loss anaemia in traumatically injured orthopaedic patients. Patients are randomised to receive either a single dose infusion of low-molecular weight iron dextran (1000 mg) or placebo (normal saline) postoperatively during their hospital stay for trauma management. Eligible subjects include adult patients admitted for lower extremity or pelvis operative fracture care with a haemoglobin of 7-11 g/dL within 7 days postoperatively during inpatient care. Exclusion criteria include history of intolerance to intravenous iron supplementation, active haemorrhage requiring ongoing blood product resuscitation, multiple planned procedures, pre-existing haematologic disorders or chronic inflammatory states, iron overload on screening or vulnerable populations. We follow patients for 3 months to measure the effect of iron supplementation on clinical outcomes (resolution of anaemia and functional iron deficiency), patient-reported outcomes (fatigue, physical function, depression and quality of life) and translational measures of immune cell function.
This study has ethics approval (Oregon Health & Science University Institutional Review Board, STUDY00022441). We will disseminate the findings through peer-reviewed publications and conference presentations.
NCT05292001; ClinicalTrials.gov.
矫形创伤和骨折护理通常会导致围手术期贫血和相关的功能性缺铁，这是由于全身炎症状态。现代严格的输血阈值使许多患者贫血；管理这种围手术期贫血是影响矫形创伤外科手术结果的机会。这项初步研究的主要结果是评估静脉铁治疗（IVIT）改善骨科损伤后患者健康状况的大型随机对照试验（RCT）的可行性。测量将包括参与者招募率、筛选失败率、随访、缺失数据、不良事件和方案偏离率。
这项单中心、初步、双盲 RCT 研究了 IVIT 在创伤性骨科患者急性失血性贫血中的应用。患者在住院期间接受创伤管理手术后，随机接受低分子右旋糖酐铁（1000mg）单次输注或安慰剂（生理盐水）。符合条件的受试者包括接受下肢或骨盆手术骨折治疗的成年患者，术后 7 天内血红蛋白为 7-11g/dL，且在住院期间接受治疗。排除标准包括对静脉铁补充不耐受的病史、需要持续输血复苏的活动性出血、多个计划手术、预先存在的血液系统疾病或慢性炎症状态、筛选时铁过载或脆弱人群。我们随访患者 3 个月，以测量铁补充对临床结局（贫血和功能性缺铁的缓解）、患者报告结局（疲劳、身体功能、抑郁和生活质量）以及免疫细胞功能的转化测量的影响。
本研究已获得俄勒冈健康与科学大学机构审查委员会的伦理批准（研究 00022441）。我们将通过同行评议的出版物和会议报告来传播研究结果。
NCT05292001；ClinicalTrials.gov。
