Anaemia MedDRA version: 14.1 Level: LLT Classification code 10066761 Term: Acute anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: Ferrous sulphate
Product Name: Ferrous sulphate
Product Code: Ferrous sulphate
Pharmaceutical Form: Tablet
INN or Proposed INN: elemental iron
Concentration unit: mg milligram(s)
Concentra
Sponsors
Brighton & Sussex University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Preoperative haemoglobin 10.0-13.0g/dl 2. Serum ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: 1. Haemoglobin 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Haemoglobin increase (from randomisation until surgery) 2. Total number and volume of packed red cells given during hospital stay following surgery 3. Total number of packs and volumes of fresh frozen plasma, platelets and cryoprecipitate given during hospital stay following surgery 4. Postoperative blood loss at 12 and 24 hours after surgery 5. Troponin T level 18-24h after surgery 6. Development of acute kidney injury defined as RIFLE-R category 7. Composite in-hospital adverse events comprising: in-hospital death; stroke; renal replacement therapy; postoperative use of intra-aortic balloon pump; return to theatre for debridement of sternal or other surgical wound 8. Re-sternotomy for bleeding within 24h of surgery 9. Occurrence of postoperative delirium or transient ischaemic attack 10.Length of postoperative hospital stay 11. Cognitive function 12. Patient-reported outcomes in quality of life and fatigue;Timepoint(s) of evaluation of this end point: Most secondary endpoints are evaluated until hospital discharge. Some (e.g. cognitive function) will be assessed until 6 weeks after surgery. Quality of life (SF36 questionnaire) will be assessed until 6 months after surgery. | — |
Countries
United Kingdom
Outcome results
None listed