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Trial record 66 of 380 for:    FERRIC CATION

Comparing Intravenous and Oral Iron in Postoperative Anemia

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ClinicalTrials.gov Identifier: NCT01913808
Recruitment Status : Completed
First Posted : August 1, 2013
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
Vifor Pharma
Information provided by (Responsible Party):
Elvira Bisbe, Parc de Salut Mar

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Postoperative Anemia Osteoarthritis, Knee Drug: Ferric carboxymaltose Drug: ferrous glycine sulphate Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Intravenous Ferric Carboxymaltose in the Improvement of Anemia in Patients With Postoperative Knee Prosthesis
Study Start Date : January 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Ferric carboxymaltose
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]
Drug: Ferric carboxymaltose
Single intravenous dose ferric carboxymaltose
Other Name: intravenous iron

Active Comparator: Ferrous glycine sulphate
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
Drug: ferrous glycine sulphate
Daily oral dose of 100 mg iron (ferrous glycine sulphate)
Other Name: Oral iron




Primary Outcome Measures :
  1. Change in hemoglobin concentration [ Time Frame: 30 days ]
    Change in hemoglobin concentrations from baseline to 30 days


Secondary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913808


Locations
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Spain
Hospital de la Esperanza (Parc de Salut MAR)
Barcelona, Spain, 08024
Sponsors and Collaborators
Parc de Salut Mar
Vifor Pharma
Investigators
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Study Director: Elvira Bisbe, MD Parc de Salut Mar
Principal Investigator: Luis Molto, MD Parc de Salut Mar

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elvira Bisbe, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01913808     History of Changes
Other Study ID Numbers: FEV-POST/ESP10
2010-023038-22 ( EudraCT Number )
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: July 2013
Keywords provided by Elvira Bisbe, Parc de Salut Mar:
Postoperative anemia
Total knee arthroplasty
Iron therapy
Additional relevant MeSH terms:
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Ferric Compounds
Osteoarthritis, Knee
Anemia
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hematologic Diseases
Iron
Glycine
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action