NCT01913808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
Last Updated

April 6, 2016

Status Verified

July 1, 2013

Enrollment Period

1.1 years

First QC Date

July 30, 2013

Last Update Submit

April 4, 2016

Conditions

Postoperative AnemiaOsteoarthritis, Knee

Keywords

Postoperative anemiaTotal knee arthroplastyIron therapy

Outcome Measures

Primary Outcomes (1)

  • Change in hemoglobin concentration

    Change in hemoglobin concentrations from baseline to 30 days

    30 days

Secondary Outcomes (6)

  • Anemia

    30 days

  • Hemoglobin concentration

    30 days

  • Quality of life

    30 days

  • Independence in daily activities

    30 days

  • Walk test

    30 days

  • +1 more secondary outcomes

Study Arms (2)

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 \[mg iron stores\]

Drug: Ferric carboxymaltose

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

Drug: ferrous glycine sulphate

Interventions

Ferric carboxymaltoseDRUG

Single intravenous dose ferric carboxymaltose

Also known as: intravenous iron
Ferric carboxymaltose
ferrous glycine sulphateDRUG

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

Also known as: Oral iron
Ferrous glycine sulphate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Esperanza (Parc de Salut MAR)

Barcelona, Barcelona, 08024, Spain

Location

Related Publications (1)

  • 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.

    PMID: 24780615DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

ferric carboxymaltoseferroglycine sulfateIron

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Elvira Bisbe, MD

    Parc de Salut Mar

    STUDY DIRECTOR

  • Luis Molto, MD

    Parc de Salut Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 1, 2013

Study Start

January 1, 2011

Primary Completion

February 1, 2012

Study Completion

January 1, 2013

Last Updated

April 6, 2016

Record last verified: 2013-07

Locations

ES(1)