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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anemia, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Drug: Iron-III Isomaltoside 1000
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with preoperative anemia following treatment protocol<br>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<br>* Protocol for optimizing preoperative Hb using IV Iron-III Isomaltoside 1000<br>* Other names: Monofer;|
| Patients with preoperative anemia - Historical control<br>Cohort of preoperative anemic patients from the Lundbeckcentre Database. Serving as a historical control | Other: Standard Care<br>* Standard Care in a historical control cohort<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion Rate | 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 |  | 4 weeks prior to surgery (baseline) | 
| Change in hemoglobin concentration | 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 | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Blood Management, Preoperative anemia, IV Iron