NCT02385383

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia
• Arthroplasty, Replacement, Hip
• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
DRUG	Iron-III Isomaltoside 1000	Protocol for optimizing preoperative Hb using IV Iron-III Isomaltoside 1000
OTHER	Standard Care	Standard Care in a historical control cohort

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-10-01
• Completion: 2017-02-01
• First posted: 2015-03-11
• Last updated: 2015-03-11

Locations

6 sites across 1 country: Denmark