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

Pre-OPerative Iron used as blood sparing technique in orthopedic surgery (total hip replacement and total knee replacement surgery, elective and no revision surgery): a three-arm randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75321849

Enrollment

1012

Registered

2013-04-23

Start date

2013-01-01

Completion date

Unknown

Last updated

2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic surgery Surgery Orthopedic surgery

Interventions

Three-arm randomised study in patients with a start Hb level > 6,1 and < = 8,1 mmol/l. Intervention groups will be compared with a control group. The intervention group will receive i

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Revision operations, preop Hb 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

Design outcomes

Primary

Measure	Time frame
1. Can ferric carboxymaltose effectively reduce RBC transfusion rate compared to controls in elective orthopedic surgery patients? 2. Rate of transfused patients	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026