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临床试验/NCT01913808
NCT01913808已完成4 期

Efficacy of Intravenous Ferric Carboxymaltose in the Improvement of Anemia in Patients With Postoperative Knee Prosthesis

Parc de Salut Mar1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
122
试验地点
1
主要终点
Change in hemoglobin concentration

研究概览

简要总结

Postoperative anaemia are common in patients undergoing major orthopaedic surgery. The main consequence of perioperative anaemia is an increased risk of red blood cell (RBC) transfusions. Allogeneic RBC transfusion and anaemia are associated with higher postoperative mortality and morbidity.

The aim of this study was to compare the efficacy of postoperative i.v. ferric carboxymaltose (FCM) and oral ferrous glycine sulphate (FS) for early improvement of postoperative anaemia after total knee arthroplasty and whether iron treatment could facilitate recovery from surgery.

详细描述

Both pre- and postoperative anaemia are common in patients undergoing major orthopaedic surgery. The main consequence of perioperative anaemia is an increased risk of red blood cell (RBC) transfusions. Allogeneic RBC transfusion and anaemia are associated with higher postoperative mortality and morbidity. Since blood transfusions increase Hb levels only transiently but come at the price of higher mortality and morbidity (e.g. postoperative infections), the three-pillar concept of patient blood management (PBM) has been developed to reduce the risk of blood transfusions and improve patient outcomes. Among its three pillars, the treatment or prevention of preoperative anaemia is the mainstay of PBM. Also the second pillar, minimisation of intraoperative blood loss,15 targets at least indirectly the patient's haemoglobin (Hb) levels.

The third PBM pillar, use of low Hb cut-off levels triggering transfusion, means that a certain degree of postoperative anaemia is taken into account. However, it remains unclear whether a lowered transfusion threshold allows optimal functional recovery and quality of life. Since patients undergoing total knee arthroplasty (TKA) are often elderly and have several comorbidities, prolonged exposure to low Hb levels is not a good option for this population. Furthermore, TKA patients should be mobilised as soon as possible after surgery which increases the metabolic demand.

Although, depending on the timescale before surgery, oral iron is suggested for preoperatively anaemic patients with absolute iron deficiency, oral iron showed no benefit over placebo in anaemic patients after lower limb arthroplasty. In patients at risk of functional iron deficiency due to chronic inflammation of different aetiologies, intravenous (i.v.) iron administration has proven its superiority over oral iron. Even in iron-deficient patients without established anaemia, i.v. iron improved physical performance and cardiac functional class. Thus, postoperative anaemia treatment with i.v. iron might not only reduce RBC requirements but also improve performance, rehabilitation and outcomes.

The aim of this study was to compare the efficacy of postoperative i.v. ferric carboxymaltose (FCM) and oral ferrous glycine sulphate (FS) for early improvement of postoperative anaemia after total knee arthroplasty and whether iron treatment could facilitate recovery from surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥18 years of age) were recruited at the scheduled preoperative visit (21 to 30 days prior surgery knee replacement). Anaemia (Hb <12 g/dL) and/or iron deficiency (TSAT <20%) the day after surgery

排除标准

  • Patients with known hypersensitivity or contraindications to iron, liver insufficiency (aspartate aminotransferase or alanine aminotransferase >60 IU/L), bronchial asthma, presence of acute or chronic infection, severe heart disease, significant history of allergies (rash, etc.) or anti-anaemia treatment within 15 days prior to surgery were excluded from participation. Also pregnant or nursing women were excluded (negative pregnancy urine test within 7 days prior first study treatment or amenorrhoea for at least 12 months).

研究组 & 干预措施

Ferric carboxymaltose

Experimental

Ferric carboxymaltose (Ferinject®, Vifor-France) was given as a single i.v. dose to correct the total iron deficit calculated by the Ganzoni formula (total iron deficit [mg] = 2.4 x patient's weight [kg] x (target Hb [13 g/dL] - current Hb [g/dL]) + 500 [mg iron stores]

干预措施: Ferric carboxymaltose (Drug)

Ferrous glycine sulphate

Active Comparator

Ferrous glycine sulphate (Ferbisol-Bial Industrial Farmacéutica, Spain) was given as a once daily oral dose of 100 mg iron from the day of discharge (Day 7) to the rehabilitation visit 30 days after surgery

干预措施: ferrous glycine sulphate (Drug)

结局指标

主要结局

Change in hemoglobin concentration

时间窗: 30 days

Change in hemoglobin concentrations from baseline to 30 days

次要结局

  • Quality of life(30 days)
  • Anemia(30 days)
  • Independence in daily activities(30 days)
  • Adverse events(30 days)
  • Hemoglobin concentration(30 days)
  • Walk test(30 days)

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elvira Bisbe

PhD

Parc de Salut Mar

研究点 (1)

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