Pre-operative Iron used as blood sparing technique in orthopedic surgery (total hip replacement and total knee replacement surgery, elective and no revision surgery)

Not Applicable

Completed

• Conditions: Orthopedic surgery; Surgery

• Registration Number: ISRCTN75321849
• Lead Sponsor: Albert Schweitzer Hospital (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-23
• Study Completion: 2015-01-01
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1012

Inclusion Criteria

Orthopedic patients > 18 years , either sex, planned for primary total hip and total knee replacement operations with an preoperative > 6.1 mmol/l is > 7 gr/l and < 8.2 mmol/l is < 13.2 gr/l

Exclusion Criteria

1. Revision operations, preop Hb <= 6.1 mmol/l or > 8.2 mmol/l
2. All patients who wish not to receive blood transfusions
3. Uncontrolled hypertension (Diastolic blood pressure > 95 mm Hg)
4. Patients planned for preoperative autologous donation, cell salvage, wound reinfusion
5. Severe cardiac compromised patients, uncontrolled hypertension, severe disease peripheral arteries, arteria carotis or arteria cerebralis
6. Recent myocardial infarction of CVA or instable angina pectoris or heart failure
7. Prone for thrombosis (f.i. Factor V Leiden)
8. All patients with Hb-globinopathy such as sickle cell anemia or thalassemia
9. Patients with oncological processes except curred malignancy or skin cancer
10. Pregnancy, patients with ciclosporin therapy
11. Impossible to give prophylactic anticoagulant
12. Allergy to Epo or i.v. iron or additives
13 Infected wound, infected prothesis, infectious process at the moment of inclusion
14. Epileptic, chronic kidney and liver insufficiency
15. Iron diseases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Can ferric carboxymaltose effectively reduce RBC transfusion rate compared to controls in elective orthopedic surgery patients?<br> 2. Rate of transfused patients<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Does i.v. iron therapy increase preoperative Hb-levels and improve postoperative recovery?<br> 2. Is this i.v. iron therapy also efficient for patients with anemia other than iron deficiency (ACD)?<br> 3. Is infusion of i.v. iron policlinically safe?<br> 4. Cost reductions caused by introduction of i.v. iron therapy - can it then replace Epo?<br> 5. Hospital stay<br> 6. Postoperative complications<br> 7. Time needed for revalidation<br> 8. Measurement of quality of life<br> 9. Total cost treatment<br> 10. Hb-levels pre- and postoperatively<br> 11. Amount of RBC per patient<br> 12. Safety of IV iron<br>