Comparing Intravenous and Oral Iron in Postoperative Anemia

NCT01913808 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2016-04-06

No results posted yet for this study

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.

Conditions

  • Postoperative Anemia
  • Osteoarthritis, Knee

Interventions

DRUG

Ferric carboxymaltose

Single intravenous dose ferric carboxymaltose

DRUG

ferrous glycine sulphate

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

Sponsors & Collaborators

  • Vifor Pharma

    collaborator INDUSTRY
  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Elvira Bisbe, MD · Parc de Salut Mar

  • Luis Molto, MD · Parc de Salut Mar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-02-29
Completion
2013-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01913808 on ClinicalTrials.gov