Comparing Intravenous and Oral Iron in Postoperative Anemia

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913808
• Other study ID #: FEV-POST/ESP10
• Secondary ID: 2010-023038-22
• Status: Completed
• Phase: Phase 4
• First received: July 30, 2013
• Last updated: April 4, 2016
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: July 2013
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Osteoarthritis, Knee
• Postoperative Anemia

Intervention

Drug:
• Ferric carboxymaltose
Single intravenous dose ferric carboxymaltose
• ferrous glycine sulphate
Daily oral dose of 100 mg iron (ferrous glycine sulphate)

Locations

Country	Name	City	State
Spain	Hospital de la Esperanza (Parc de Salut MAR)	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Vifor Pharma

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin concentration	Change in hemoglobin concentrations from baseline to 30 days	30 days	No
Secondary	Anemia	Number of subjects without anemia (hemoglobin > 12g/dL)	30 days	No
Secondary	Hemoglobin concentration	Concentration of hemoglobin at day 30	30 days	No
Secondary	Quality of life	Quality of life measured by European Quality of Life-5 Dimensions (EQ-5D)(before and 30 days)	30 days	No
Secondary	Independence in daily activities	Independence in daily activities measured by the Barthel questionnaire (before and 30 days)	30 days	No
Secondary	Walk test	6 minutes walking test (before and 30 days)	30 days	No
Secondary	Adverse events	Adverse event (clinical and analytical, before to 30 days)	30 days	Yes