Lee Seung Hyun, Shim Jae-Kwang, Soh Sarah, Song Jong Wook, Chang Byung Chul, Lee Sak, Kwak Young-Lan
Department of Thoracic and Cardiovascular Surgery, Severance Cardiovascular Hospital, Yonsei University Health System, College of Medicine, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University Health System, Yonsei, Republic of Korea.
Trials. 2018 Jul 4;19(1):350. doi: 10.1186/s13063-018-2545-3.
Anemia is a frequent complication after cardiac surgery especially following reoperation due to previous prosthetic valve failure or multiple valve surgery (including combined coronary artery bypass grafting). This trial explores whether intravenously administered iron isomaltoside 1000 (Monofer®) results in better clinical outcomes in patients undergoing complex heart valve surgery who are expected to receive transfusion.
METHODS/DESIGN: In this prospective, single-center, double-blinded, randomized controlled trial, 214 patients undergoing reoperation or multiple valve surgery are randomly allocated to either the iron isomaltoside 1000 (IVFe) or the control group from August 2016 to August 2018. The IVFe group receives iron isomaltoside 1000 mg (maximum dose 20 mg/kg) intravenously 3 days before and after the surgery. The control group receives an equivalent volume of normal saline. The primary endpoint is transfusion requirement (more than 1 unit of packed erythrocytes) for postoperative care until discharge and secondary endpoint are major complications, such as delayed ventilator therapy, acute kidney injury, and mortality. Reticulocyte count, plasma hepcidin, iron profiles (serum iron, serum ferritin, total iron-binding capacity, transferrin, transferrin saturation), coagulation profiles, urinary analysis, and chemical profiles are measured for three preoperative baseline-data days and just before surgery, except for hepcidin. After surgery, daily routine basic laboratory tests are measured just before discharge and reticulocyte count, iron profiles, and hepcidin are repeatedly checked for three postoperative days.
From our study, we can clarify the following points: the first is the perioperative IVFe effect on the demand for transfusion, and clinical outcomes in reoperation or complex valve surgery and the second is the role of hepcidin in the effect of IVFe on the hemoglobin level increase.
ClinicalTrials.gov , Identifier: NCT02862665 . Registered on August 2016.
贫血是心脏手术后常见的并发症，尤其是在因先前人工瓣膜功能衰竭或多次瓣膜手术（包括联合冠状动脉搭桥术）而进行再次手术之后。本试验旨在探讨静脉注射异麦芽糖酐铁1000（Monofer®）是否能使预期接受输血的复杂心脏瓣膜手术患者获得更好的临床结局。
方法/设计：在这项前瞻性、单中心、双盲、随机对照试验中，2016年8月至2018年8月期间，214例接受再次手术或多次瓣膜手术的患者被随机分配至异麦芽糖酐铁1000（IVFe）组或对照组。IVFe组在手术前3天和术后3天静脉注射1000毫克异麦芽糖酐铁（最大剂量20毫克/千克）。对照组接受等量的生理盐水。主要终点是术后直至出院的输血需求（超过1单位浓缩红细胞），次要终点是主要并发症，如延迟通气治疗、急性肾损伤和死亡率。除了铁调素外，在术前三个基线数据日和手术前测量网织红细胞计数、血浆铁调素、铁参数（血清铁、血清铁蛋白、总铁结合力、转铁蛋白、转铁蛋白饱和度）、凝血参数、尿液分析和化学参数。术后，在出院前测量每日常规基本实验室检查，并在术后三天重复检查网织红细胞计数、铁参数和铁调素。
从我们的研究中，我们可以阐明以下几点：第一是围手术期IVFe对再次手术或复杂瓣膜手术中输血需求和临床结局的影响，第二是铁调素在IVFe对血红蛋白水平升高影响中的作用。
ClinicalTrials.gov，标识符：NCT02862665。于2016年8月注册。
