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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41421863

Enrollment

320

Registered

2012-08-28

Start date

2012-09-15

Completion date

Unknown

Last updated

2020-09-21

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

Conditions

Preoperative anemia, cardiac surgery Surgery

Interventions

1. Monofer® [iron isomaltoside 1000] 1000mg, single dose, i.v. (or Ferinject® [ferric carboxymaltose] 1000mg, single dose i.v. if Monofer® contraindicated) AND Aranesp® (darbepoetin) 200 µg, single d

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Hb 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

Design outcomes

Primary

Measure	Time frame
Proportion of participants in each study arm that receives one or more packed red cell transfusion between the start of surgery until the end of the fifth postoperative day	—

Secondary

Measure	Time frame
1. Hemoglobin increase between randomisation and surgery 2. Total number of packs and volume of red cells transfused from the start of surgery until hospital discharge 3. Postoperative blood loss at 12 and 24 hours after surgery 4. Significant postoperative myocardial injury as measured by Troponin level 18-24h after surgery 5. Acute renal failure as defined by greater than 1.5 times increase in creatinine level after surgery 6. Length of hospital stay	—

Measure

Time frame

1. Hemoglobin increase between randomisation and surgery 2. Total number of packs and volume of red cells transfused from the start of surgery until hospital discharge 3. Postoperative blood loss at 12 and 24 hours after surgery 4. Significant postoperative myocardial injury as measured by Troponin level 18-24h after surgery 5. Acute renal failure as defined by greater than 1.5 times increase in creatinine level after surgery 6. Length of hospital stay

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Countries

United Kingdom

Outcome results

None listed

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