Health Condition 1: C40-C41- Malignant neoplasms of bone and articular cartilage
Conditions
Interventions
Intervention1: Multimodal haeamtopoietic bundle (parenteral plus oral): 1. IV Ferric derisomaltose 1.0gram or 20 mg per kg in 100mL NS over one hour.
2. Vitamin B12 ( Methylcobalamine) 500mcg in 100mL
Sponsors
All India Institute of Medical Sciences (AIIMS), New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients above or at 18 years of age. 2. Underwent major orthopaedic malignancy surgery with predicted intraoperative blood loss of 2 litres or more than or more than or equal to 40 percentage of blood volume. 3. Intraoperative blood transfusion of more than or equal to 4 units of PRBC. 4. Post-operative day 1 (POD-1) haemoglobin in moderate anaemia range (8-11 grams per dL). 5. Provision of written informed consent
Exclusion criteria
Exclusion criteria: 1. The patient refused to participate in the study. 2. Patients with known haematological disorders (thalassemia, sickle cell disease, myelodysplastic syndromes). 3. Patients known to have a hypersensitivity reaction to intravenous iron, erythropoietin, vitamin B12 and folic acid) 4. Patients with chronic kidney disease require dialysis. 5. Pregnant female and breastfeeding mothers. 6. Patients with uncontrolled hypertension. 7. Patients with severe liver dysfunction (Child-Pugh grade C). 8. Ongoing infection or sepsis. 9. Patients previously on long-term iron or erythropoietin treatment. 10. Patients with seizure disorders on anti-epileptic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Comparison of hemoglobin levels in the postoperative period between both the groups.Timepoint: Postoperative days 1, 7 and 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Identify the number of patients who remain anemic on 28th day postoperative as per WHO criteria of anemia. 2. Comparing the RBC indices (MCV, MCH, MCHC and RDW) on POD 7 and 28 in both the patient groups. 3. Comparing the reticulocyte counts on preoperative and POD 7 (or before discharge whichever is earlier) 4. Record the iron profile changes (serum iron, ferritin, transferrin saturation and TIBG) on POD 0 and 28. 5. To assess the safety and tolerability of intravenous iron formulation in patients. 6. To assess the safety of erythropoietin in patients. 7. Compare the length of hospital stay between both the groups. 8. Presence of any post-operative surgical site infections in both the groups. Timepoint: Postoperative days 1, 7 and 28. | — |
Countries
India
Contacts
Public ContactRakesh Kumar
All India Institue of Medical Sciences (AIIMS), New Delhi
Outcome results
None listed