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

• Conditions: Anemia; Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip
• Interventions: Drug: Iron-III Isomaltoside 1000; Other: Standard Care

• Registration Number: NCT02385383
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-02-16
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-10
• Last Update Submitted: 2015-03-10
• Study First Posted: 2015-03-11
• Last Update Posted: 2015-03-11
• Primary Completion: 2016-10
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with preoperative anemia following treatment protocol	Iron-III Isomaltoside 1000	Patients with preoperative anemia according to the WHO definition and treated with a protocol of Iitravenous iron prior to surgery
Patients with preoperative anemia - Historical control	Standard Care	Cohort of preoperative anemic patients from the Lundbeckcentre Database. Serving as a historical control

Primary Outcome Measures

Name	Time	Method
Transfusion Rate	From date of admission to date of discharge (up to 30 days)	Blood transfusion (yes/no) during the entire hospital stay

Secondary Outcome Measures

Name	Time	Method
Classification of preoperative anemia	4 weeks prior to surgery (baseline)
Change in hemoglobin concentration	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
No. of red blood cell units administered per patient	From date of admission to date of discharge (up to 30 days)	No of blood units administered during the entire hospital stay
Length of Hospital stay	From date of admission to Date of discharge (up to 30 days)
Postoperative complications and readmissions	From date of surgery up to 90 days after surgery

Trial Locations

Locations (6)

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