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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02385383
• Other study ID #: RH-4074-OJ4
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2015
• Last updated: March 10, 2015
• Start date: October 2014
• Est. completion date: February 2017

Study information

• Verified date: March 2015
• Source: Rigshospitalet, Denmark
• Contact: Oeivind Jans, M.D., Ph.D.
• Phone: +4521688012
• Email: oeivind.jans[@]rh.regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Denmark	Bisbebjerg Hospital, Dept. of orthopedic surgery	Copenhagen NV
Denmark	Farsø Sygehus	Farsø
Denmark	Gentofte Hospital, Dept. of orthopedic surgery	Hellerup
Denmark	Hvidovre Hospital, Department of orthopaedic surgery	Hvidovre
Denmark	Vejle Sygehus, Dept. of orthopedic surgery	Vejle
Denmark	Viborg Sygehus, Dept. of orthopedic surgery	Viborg

Sponsors (7)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Bisbebjerg Hospital, Farsø Sygehus, Gentofte Hospital, Hvidovre University Hospital, Regionshospitalet Viborg, Skive, Vejle Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfusion Rate	Blood transfusion (yes/no) during the entire hospital stay	From date of admission to date of discharge (up to 30 days)	No
Secondary	Classification of preoperative anemia		4 weeks prior to surgery (baseline)	No
Secondary	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
Secondary	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)	No
Secondary	Length of Hospital stay		From date of admission to Date of discharge (up to 30 days)	No
Secondary	Postoperative complications and readmissions		From date of surgery up to 90 days after surgery	No