An Intravenous Iron Based Protocol for Preoperative Anaemia in Hip and Knee Surgery - An Observational Study
NCT ID: NCT02385383
Last Updated: 2015-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2014-10-31
2017-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Iron-III Isomaltoside 1000
Protocol for optimizing preoperative Hb using IV Iron-III Isomaltoside 1000
Patients with preoperative anemia - Historical control
Cohort of preoperative anemic patients from the Lundbeckcentre Database. Serving as a historical control
Standard Care
Standard Care in a historical control cohort
Interventions
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Iron-III Isomaltoside 1000
Protocol for optimizing preoperative Hb using IV Iron-III Isomaltoside 1000
Standard Care
Standard Care in a historical control cohort
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Not able to give consent
18 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Bispebjerg Hospital
OTHER
Gentofte Hospital
UNKNOWN
Vejle Sygehus
UNKNOWN
Regionshospitalet Viborg, Skive
OTHER
Farsø Sygehus
UNKNOWN
Rigshospitalet, Denmark
OTHER
Responsible Party
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Oeivind Jans
M.D., Ph.D.
Principal Investigators
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Oeivind Jans, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Bisbebjerg Hospital, Dept. of orthopedic surgery
Copenhagen NV, , Denmark
Farsø Sygehus
Farsø, , Denmark
Gentofte Hospital, Dept. of orthopedic surgery
Hellerup, , Denmark
Hvidovre Hospital, Department of orthopaedic surgery
Hvidovre, , Denmark
Vejle Sygehus, Dept. of orthopedic surgery
Vejle, , Denmark
Viborg Sygehus, Dept. of orthopedic surgery
Viborg, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Søren Solgaard, M.D.
Role: primary
Per Kjærsgaard-Andersen, M.D.
Role: primary
Other Identifiers
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RH-4074-OJ4
Identifier Type: -
Identifier Source: org_study_id
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