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Completed

NCT Number: NCT01913808

Comparing Intravenous and Oral Iron in Postoperative Anemia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de la Esperanza (Parc de Salut MAR)

Barcelona, 08024, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

ferric carboxymaltose

Drug

Single intravenous dose ferric carboxymaltose

Other names: intravenous iron

Ferrous glycine sulphate

Drug

Daily oral dose of 100 mg iron (ferrous glycine sulphate)

Other names: Oral iron

Primary outcomes

  1. Change in hemoglobin concentration

    Time frame: 30 days

    Change in hemoglobin concentrations from baseline to 30 days

Secondary outcomes

  1. Anemia

    Time frame: 30 days

    Number of subjects without anemia (hemoglobin > 12g/dL)

  2. Hemoglobin concentration

    Time frame: 30 days

    Concentration of hemoglobin at day 30

  3. Quality of life

    Time frame: 30 days

    Quality of life measured by European Quality of Life-5 Dimensions (EQ-5D)(before and 30 days)

  4. Independence in daily activities

    Time frame: 30 days

    Independence in daily activities measured by the Barthel questionnaire (before and 30 days)

  5. Walk test

    Time frame: 30 days

    6 minutes walking test (before and 30 days)

  6. Adverse events

    Time frame: 30 days

    Adverse event (clinical and analytical, before to 30 days)

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Vifor Pharma

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Aug 1, 2013
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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