An Intravenous Iron Based Protocol for Preoperative Anaemia in Hip and Knee Surgery - An Observational Study

March 10, 2015 updated by: Oeivind Jans, Rigshospitalet, Denmark

An Intravenous Iron Based Protocol for Optimizing Haemoglobin in Anaemic Patients Prior to Fast-track Hip and Knee Arthroplasty - An Observational Follow up Study

This observational study follows a cohort of patients scheduled for elective hip- or knee surgery but has preoperative anemia and are treated with Intravenous (IV) iron prior to surgery according to a recently introduced standardized treatment protocol at 6 high-volume surgical centres.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients presenting with preoperative anaemia prior to hip and knee arthroplasty has a high risk of receiving allogeneic blood transfusion and anaemia has been associated with increased postoperative morbidity and mortality. While IV-iron administration may raise Hb prior to surgery, existing guidelines for addressing and treating preoperative anaemia is not widely implemented for patients scheduled for elective total joint arthroplasty (TJA) in Denmark. In addition, causes of preoperative anaemia and the efficacy of preoperative IV-iron administration has not been sufficiently evaluated in elective TJA.

This is a observational follow-up study among 6 Danish high volume surgical centres that has recently introduced a standardized anaemia screening and treatment protocol for patients with preoperative anaemia scheduled for total hip- or knee arthroplasty.

Patients with iron deficiency anaemia or anaemia of chronic inflammation receive infusion of IV-iron (Monofer) 4 weeks prior to surgery as a part of the standard operating procedure on the department.

The aim of this follow up study is to evaluate changes in Haemoglobin concentration, transfusion rate and postoperative morbidity in this cohort.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Copenhagen NV, Denmark, 2400
        • Recruiting
        • Bisbebjerg Hospital, Dept. of orthopedic surgery
        • Principal Investigator:
          • Jens Bagger, M.D.
      • Farsø, Denmark, 9640
        • Recruiting
        • Farsø Sygehus
      • Hellerup, Denmark, 2900
        • Recruiting
        • Gentofte Hospital, Dept. of orthopedic surgery
        • Contact:
          • Søren Solgaard, M.D.
        • Principal Investigator:
          • Søren Solgaard
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Hvidovre Hospital, Department of orthopaedic surgery
        • Contact:
        • Principal Investigator:
          • Henrik Husted
      • Vejle, Denmark, 7100
        • Recruiting
        • Vejle Sygehus, Dept. of orthopedic surgery
        • Contact:
          • Per Kjærsgaard-Andersen, M.D.
        • Principal Investigator:
          • Per Kjærsgaard-Andersen, M.D.
      • Viborg, Denmark, 8800
        • Recruiting
        • Viborg Sygehus, Dept. of orthopedic surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for elective hip or knee arthroplasty presenting with preoperative anemia.

Description

Inclusion Criteria:

  • Age > 18 years
  • Scheduled for elective primary hip- or knee arthroplasty
  • Preoperative hemoglobin < 13 g/dl (males) or < 12 g/dl (females)
  • Included in the departments treatment protocol for preoperative anemia

Exclusion Criteria:

  • Cronic transfusion need
  • Not able to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with preoperative anemia following treatment protocol
Patients with preoperative anemia according to the WHO definition and treated with a protocol of Iitravenous iron prior to surgery
Drug: Iron-III Isomaltoside 1000
Protocol for optimizing preoperative Hb using IV Iron-III Isomaltoside 1000
Other Names:
  • Monofer
Patients with preoperative anemia - Historical control
Cohort of preoperative anemic patients from the Lundbeckcentre Database. Serving as a historical control
Other: Standard Care
Standard Care in a historical control cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfusion Rate
Time Frame: From date of admission to date of discharge (up to 30 days)
Blood transfusion (yes/no) during the entire hospital stay
From date of admission to date of discharge (up to 30 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Classification of preoperative anemia
Time Frame: 4 weeks prior to surgery (baseline)
4 weeks prior to surgery (baseline)
Change in hemoglobin concentration
Time Frame: From date of preoperative blood sampling (baseline) to date of admission (Up to 4 weeks)
The change in Hb from the time of preoperative blood sampling to Hb sampled on the date of admission
From date of preoperative blood sampling (baseline) to date of admission (Up to 4 weeks)
No. of red blood cell units administered per patient
Time Frame: From date of admission to date of discharge (up to 30 days)
No of blood units administered during the entire hospital stay
From date of admission to date of discharge (up to 30 days)
Length of Hospital stay
Time Frame: From date of admission to Date of discharge (up to 30 days)
From date of admission to Date of discharge (up to 30 days)
Postoperative complications and readmissions
Time Frame: From date of surgery up to 90 days after surgery
From date of surgery up to 90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Hvidovre University Hospital
Bispebjerg Hospital
Regionshospitalet Viborg, Skive
Gentofte Hospital
Vejle Sygehus
Farsø Sygehus

Investigators

  • Principal Investigator: Oeivind Jans, M.D., Ph.D., Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

February 16, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RH-4074-OJ4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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