Is intravenous iron and darbepoetin more effective than oral iron in reducing blood transfusion requirements for patients undergoing cardiac surgery?

Not Applicable

Completed

• Conditions: Preoperative anemia, cardiac surgery; Surgery

• Registration Number: ISRCTN41421863
• Lead Sponsor: Brighton & Sussex University Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-28
• Study Completion: 2019-05-16
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1. Preoperative Hb 10-13 g/dl
2. Serum ferritin <100µg/l or 100-800 µg/L with transferrin saturation <30%
3. First time cardiac surgery involving one or more of the following: coronary artery bypass grafting, repair or replacement of cardiac valve/s or ascending aorta
4. Surgery is elective - not an emergency or patient is not an inpatient immediately prior to surgery

Exclusion Criteria

1. Hb <10 g/dl or >13 g/dl
2. Patient intends to refuse allogeneic blood transfusion
3. Patient is receiving renal replacement therapy (peritoneal or hemodialysis) before surgery
4. Patient has a history of allergic or toxic reaction to any of the study drugs
5. Patient has significant acute or chronic hepatic disease
6. Patient is undergoing chemotherapy
7. Redo cardiac surgery (i.e. second time or more)
8. Proposed surgery will require hypothermic circulatory arrest
9. Pregnant
10. Age <18
11. Lacks mental capacity to give consent
12. Already participating in another clinical trial that could interfere with this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified