Clinical trial NCT02385383: An Intravenous Iron Based Protocol for Preoperative Anaemia in Hip and Knee Surgery - An Observational Study
Official title: An Intravenous Iron Based Protocol for Optimizing Haemoglobin in Anaemic Patients Prior to Fast-track Hip and Knee Arthroplasty - An Observational Follow up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Keywords: Patient Blood Management
Preoperative anemia
IV Iron
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
name: Bispebjerg Hospital
name: Gentofte Hospital
name: Vejle Sygehus
name: Regionshospitalet Viborg, Skive
name: Farsø Sygehus
First posted: 2015-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective hip or knee arthroplasty presenting with preoperative anemia.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Transfusion Rate
timeFrame: From date of admission to date of discharge (up to 30 days)
Secondary outcomes:
measure: Classification of preoperative anemia
timeFrame: 4 weeks prior to surgery (baseline)
measure: Change in hemoglobin concentration
timeFrame: From date of preoperative blood sampling (baseline) to date of admission (Up to 4 weeks)
measure: No. of red blood cell units administered per patient
timeFrame: From date of admission to date of discharge (up to 30 days)
measure: Length of Hospital stay
timeFrame: From date of admission to Date of discharge (up to 30 days)
measure: Postoperative complications and readmissions
timeFrame: From date of surgery up to 90 days after surgery
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bisbebjerg Hospital, Dept. of orthopedic surgery
city: Farsø
country: Denmark
facility: Farsø Sygehus
city: Hellerup
country: Denmark
facility: Gentofte Hospital, Dept. of orthopedic surgery
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Department of orthopaedic surgery
city: Vejle
country: Denmark
facility: Vejle Sygehus, Dept. of orthopedic surgery
city: Viborg
country: Denmark
facility: Viborg Sygehus, Dept. of orthopedic surgery
Study officials:
affiliation: Rigshospitalet, Denmark
name: Oeivind Jans, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: