Treatment of a low blood count before heart surgery comparing iron supplements taken by mouth and the combination of iron given by intravenous drip and a drug to increase the blood count

Conditions: Anaemia
MedDRA version: 14.1Level: LLTClassification code 10066761Term: Acute anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2011-003695-36-GB

Lead Sponsor: Brighton & Sussex University Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

1. Preoperative haemoglobin 10.0-13.0g/dl 2. Serum ferritin <100 mcg/L or 100-800 mcg/L AND transferrin saturation <30% 3. Scheduled first time cardiac surgery - coronary artery bypass grafting and/or repair/replacement of cardiac valve/s or ascending aorta 4. Elective surgery i.e. not continuously an in-patient between study enrolment and surgery
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

1. Haemoglobin <10.0 or>13.0 g/dl 2. Patient intends to refuse allogeneic blood transfusion in the perioperative period 3. Patient is receiving renal replacement therapy - haemodialysis or peritoneal dialysis 4. Patient has history of allergic or toxic reaction to any of the study drugs (ferrous sulphate, darbepoetin or Monofer or Ferrinject) or other intravenous iron preparation 5. Patient has significant acute or chronic hepatic disease - defined clinically 6. Patient is undergoing chemotherapy for cancer 7. Redo cardiac surgery 8. Planned surgery requires hypothermic (<30 deg C)circulatory arrest 9. Pregnant 10. Age<18 years 11. Lacks mental capcity to consent 12. Already taking part in another study that could affect the primary endpoint (blood transfusion)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In patients who have a low haemoglobin level before surgery, will treatment using a combination of intravenous iron and darbepoetin result in less blood transfusion after heart surgery than treatment using iron tablets alone.;Secondary Objective: Will the use of intravenous iron and darbepoetin, compared to iron tablets, to treat a low haemoglobin before surgery reduce 1. the average volume of blood transfused 2. the length of hospital stay after surgery 3. serious complications after heart surgery, What effect will the treatments have on mental function, feeelings of fatigue and perception of the quality of life before and after surgery;Primary end point(s): Proportion of patients in each group that receives one or more packed red cell transfusion between the start of surgery and the end of the fifth postoperative day.;Timepoint(s) of evaluation of this end point: Between start of surgery until the end of the fifth postoperative day, where day of surgery is Day 0.

Secondary Outcome Measures