Garrido-Martín Pilar, Nassar-Mansur Mohamed Ibrahim, de la Llana-Ducrós Ramiro, Virgos-Aller Tirso Ma, Rodríguez Fortunez Patricia María, Ávalos-Pinto Rosa, Jimenez-Sosa Alejandro, Martínez-Sanz Rafael
Department of Cardiovascular Surgery, Hospital Universitario de Canarias, University of La Laguna, La Laguna, Santa Cruz de Tenerife, Spain.
Interact Cardiovasc Thorac Surg. 2012 Dec;15(6):1013-8. doi: 10.1093/icvts/ivs344. Epub 2012 Aug 31.
Anaemia is a frequent complication after cardiopulmonary bypass surgery. Iron therapy has been variably employed by medical centres over the years. In our study we test the clinical effectiveness of intravenous and oral iron supplementation in correcting anaemia, and its impact on blood transfusion requirements, in patients undergoing cardiopulmonary bypass surgery.
A double-blind, randomized, placebo-controlled clinical trial with three parallel groups of patients. Group I (n = 54): intravenous iron(III)-hydroxide sucrose complex, three doses of 100 mg/24 h during pre- and postoperative hospitalization and 1 pill/24 h of oral placebo in the same period and during 1 month after discharge. Group II (n = 53): oral ferrous fumarate iron 1 pill/24 h pre- and postoperatively and during 1 month after discharge, and intravenous placebo while hospitalized. Group III (n = 52): oral and intravenous placebo pre- and postoperatively, following the same protocol. Data were collected preoperatively, at theatre, at intensive care unit admission, before hospital discharge and 1 month later.
(1) Baseline clinical and demographic characteristics and surgical procedures were similar in the three groups; (2) no inter-group differences were found in haemoglobin and haematocrit during the postoperative period; (3) the intravenous iron group showed higher serum ferritin levels at hospital discharge (1321 ± 495 ng/ml; P < 0.001) and 1 month later (610 ± 387; P < 0.001) compared with the other groups and (4) we did not observe statistical differences in blood transfusion requirements between the three groups.
The use of intravenous or oral iron supplementation proved ineffective in correcting anaemia after cardiopulmonary bypass and did not reduce blood transfusion requirements. [Current Controlled Trials number: NCT01078818 (oral and intravenous iron in patients postoperative cardiovascular surgery under EC)].
贫血是体外循环心脏手术后常见的并发症。多年来，各医疗中心对铁剂治疗的使用情况不一。在我们的研究中，我们测试了静脉和口服补充铁剂对体外循环心脏手术患者纠正贫血的临床效果及其对输血需求的影响。
一项双盲、随机、安慰剂对照的临床试验，患者分为三个平行组。第一组（n = 54）：静脉注射氢氧化铁蔗糖复合物，术前和术后住院期间每天3剂，每剂100 mg，出院后1个月内每天1丸口服安慰剂。第二组（n = 53）：术前、术后及出院后1个月内每天口服1丸富马酸亚铁，住院期间静脉注射安慰剂。第三组（n = 52）：术前、术后口服和静脉注射安慰剂，方案相同。在术前、手术时、重症监护病房入院时、出院前和1个月后收集数据。
（1）三组患者的基线临床、人口统计学特征和手术操作相似；（2）术后血红蛋白和血细胞比容无组间差异；（3）与其他组相比，静脉补铁组出院时（1321±495 ng/ml；P<0.001）和1个月后（610±387；P<0.001）血清铁蛋白水平较高；（4）三组间输血需求无统计学差异。
静脉或口服补充铁剂对纠正体外循环后贫血无效，也未降低输血需求。[当前对照试验编号：NCT01078818（欧洲委员会资助的心血管手术后患者口服和静脉补铁）]
