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| Name | Class |
|---|---|
| Hvidovre University Hospital | OTHER |
| Bispebjerg Hospital | OTHER |
| Gentofte Hospital | OTHER |
| Vejle Sygehus |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Patients with preoperative anemia - Historical control | Cohort of preoperative anemic patients from the Lundbeckcentre Database. Serving as a historical control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron-III Isomaltoside 1000 | Drug | Protocol for optimizing preoperative Hb using IV Iron-III Isomaltoside 1000 |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for elective hip or knee arthroplasty presenting with preoperative anemia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oeivind Jans, M.D., Ph.D. | Contact | +4521688012 | oeivind.jans@rh.regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Oeivind Jans, M.D., Ph.D. | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bisbebjerg Hospital, Dept. of orthopedic surgery | Recruiting | Copenhagen NV | 2400 | Denmark |
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| UNKNOWN |
| Regionshospitalet Viborg, Skive | OTHER |
| Farsø Sygehus | UNKNOWN |
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|
| Standard Care | Other | Standard Care in a historical control cohort |
|
| 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 |
| Farsø Sygehus | Recruiting | Farsø | 9640 | Denmark |
| Gentofte Hospital, Dept. of orthopedic surgery | Recruiting | Hellerup | 2900 | Denmark |
|
| Hvidovre Hospital, Department of orthopaedic surgery | Recruiting | Hvidovre | 2650 | Denmark |
|
| Vejle Sygehus, Dept. of orthopedic surgery | Recruiting | Vejle | 7100 | Denmark |
|
| Viborg Sygehus, Dept. of orthopedic surgery | Recruiting | Viborg | 8800 | Denmark |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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