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Comparing Intravenous and Oral Iron in Postoperative Anemia

Primary Purpose

Postoperative Anemia, Osteoarthritis, Knee

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Ferric carboxymaltose
ferrous glycine sulphate
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Anemia focused on measuring Postoperative anemia, Total knee arthroplasty, Iron therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital de la Esperanza (Parc de Salut MAR)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferric carboxymaltose

Ferrous glycine sulphate

Arm Description

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]

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

Outcomes

Primary Outcome Measures

Change in hemoglobin concentration
Change in hemoglobin concentrations from baseline to 30 days

Secondary Outcome Measures

Anemia
Number of subjects without anemia (hemoglobin > 12g/dL)
Hemoglobin concentration
Concentration of hemoglobin at day 30
Quality of life
Quality of life measured by European Quality of Life-5 Dimensions (EQ-5D)(before and 30 days)
Independence in daily activities
Independence in daily activities measured by the Barthel questionnaire (before and 30 days)
Walk test
6 minutes walking test (before and 30 days)
Adverse events
Adverse event (clinical and analytical, before to 30 days)

Full Information

First Posted
July 30, 2013
Last Updated
April 4, 2016
Sponsor
Parc de Salut Mar
Collaborators
Vifor Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01913808
Brief Title
Comparing Intravenous and Oral Iron in Postoperative Anemia
Official Title
Efficacy of Intravenous Ferric Carboxymaltose in the Improvement of Anemia in Patients With Postoperative Knee Prosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
Collaborators
Vifor Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Anemia, Osteoarthritis, Knee
Keywords
Postoperative anemia, Total knee arthroplasty, Iron therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferric carboxymaltose
Arm Type
Experimental
Arm Description
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]
Arm Title
Ferrous glycine sulphate
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ferric carboxymaltose
Other Intervention Name(s)
intravenous iron
Intervention Description
Single intravenous dose ferric carboxymaltose
Intervention Type
Drug
Intervention Name(s)
ferrous glycine sulphate
Other Intervention Name(s)
Oral iron
Intervention Description
Daily oral dose of 100 mg iron (ferrous glycine sulphate)
Primary Outcome Measure Information:
Title
Change in hemoglobin concentration
Description
Change in hemoglobin concentrations from baseline to 30 days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Anemia
Description
Number of subjects without anemia (hemoglobin > 12g/dL)
Time Frame
30 days
Title
Hemoglobin concentration
Description
Concentration of hemoglobin at day 30
Time Frame
30 days
Title
Quality of life
Description
Quality of life measured by European Quality of Life-5 Dimensions (EQ-5D)(before and 30 days)
Time Frame
30 days
Title
Independence in daily activities
Description
Independence in daily activities measured by the Barthel questionnaire (before and 30 days)
Time Frame
30 days
Title
Walk test
Description
6 minutes walking test (before and 30 days)
Time Frame
30 days
Title
Adverse events
Description
Adverse event (clinical and analytical, before to 30 days)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elvira Bisbe, MD
Organizational Affiliation
Parc de Salut Mar
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luis Molto, MD
Organizational Affiliation
Parc de Salut Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Esperanza (Parc de Salut MAR)
City
Barcelona
ZIP/Postal Code
08024
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24780615
Citation
Bisbe E, Molto L, Arroyo R, Muniesa JM, Tejero M. Randomized trial comparing ferric carboxymaltose vs oral ferrous glycine sulphate for postoperative anaemia after total knee arthroplasty. Br J Anaesth. 2014 Sep;113(3):402-9. doi: 10.1093/bja/aeu092. Epub 2014 Apr 29.
Results Reference
derived

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Comparing Intravenous and Oral Iron in Postoperative Anemia

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