Anemia, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
Conditions
Keywords
Patient Blood Management, Preoperative anemia, IV Iron
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.
Interventions
DRUGIron-III Isomaltoside 1000
Protocol for optimizing preoperative Hb using IV Iron-III Isomaltoside 1000
OTHERStandard Care
Standard Care in a historical control cohort
Sponsors
Hvidovre University Hospital
Bispebjerg Hospital
Gentofte Hospital
Vejle Sygehus
Regionshospitalet Viborg, Skive
Farsø Sygehus
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transfusion Rate | From date of admission to date of discharge (up to 30 days) | Blood transfusion (yes/no) during the entire hospital stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Denmark
Contacts
Primary ContactOeivind Jans, M.D., Ph.D.
Outcome results
None listed