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

Rigshospitalet

Status: Unknown

Conditions: Anemia; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Treatments: Other: Standard Care; Drug: Iron-III Isomaltoside 1000

Study type: Observational

Funder types: Other

Identifiers

NCT02385383

RH-4074-OJ4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Patients with preoperative anemia following treatment protocol

Description:

Patients with preoperative anemia according to the WHO definition and treated with a protocol of Iitravenous iron prior to surgery

Treatment:

Drug: Iron-III Isomaltoside 1000

Patients with preoperative anemia - Historical control

Description:

Cohort of preoperative anemic patients from the Lundbeckcentre Database. Serving as a historical control

Treatment:

Other: Standard Care