Pre-operatieve Iron” use as blood sparing technique in Orthopedic Surgery (THP en TKP surgery, elective and no revision surgery).
- Registration Number
- NL-OMON22057
- Lead Sponsor
- no sponsor
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1020
Inclusion Criteria
Orthopedic patients planned for primary Total Hip and total Knee replacement operations with an preoperative Hb > 6,1 and ≤ 8,1 mmol/l.
Exclusion Criteria
1. Revision operations;
2. Preop Hb <= 6,1 mmol/l or > 8,2 mmol/l;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Can ferric carboxymaltose effectively reduce RBC transfusion rate compared to controles in elective orthopaedic surgery patients?<br><br /><br /><br>Primary endpoints: Rate of transfused patients.
- Secondary Outcome Measures
Name Time Method 1. Is i.v. iron therapy increase preoperative Hb-levels and improve postoperative recovery;<br /><br>2. Is this i.v. iron therapy also efficient for patients with anemia other than iron deficiency (ACD);<br /><br>3. Is infusion of i.v. iron policlinically safe?;<br /><br>4. Cost reductions caused by introduction of i.v. iron therapy (can it then replace Epo?).<br><br /><br /><br>Secundary endpoints:<br /><br>Hospital stay, postoperative complications, time needed for revalidation, measurement of quality of life, total cost treatment, Hb-levels preo- and postoperatively, amount of RBC per patient, safety of IV iron.