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Comparing the benefits of treatment with iron tablet vs iron injections in reducing need for blood during operations of food pipe cancers in patients with anemia due to the lack of iron in the body

Evaluating the relative efficacy of preoperative intravenous vs oral iron supplementation in reducing perioperative allogenic blood transfusions in patients of gastrointestinal malignancies with iron deficiency anemia: a randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073346
Enrollment
114
Registered
2024-09-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: IV IRON: These patients will receive the calculated dose of iron (as per the deficit calculation done using the Ganzoni formula) using intravenous injection Ferric carboxymaltose soluti

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA class I-III, scheduled to undergo elective surgeries for gastro-intestinal malignancies at least 4 weeks after presenting to the OPD with iron deficiency anemia

Exclusion criteria

Exclusion criteria: Patients who are on oral iron therapy at the time of recruitment or erythropoietin within 12 weeks before recruitment Patients with symptomatic anemia requiring blood transfusions Anemia due to vitamin B12 or folate deficiency, hemolytic diseases, hemoglobinopathies or thalassemia Patients who have known allergy/ hypersensitivity to any of the study drugs Patients who are unable to take orally Unoptimized reactive airway diseases, not on inhaled corticosteroids Patients with chronic renal failure Patients with untreated hypophosphatemia, vitamin D deficiency and hyperparathyroidism (in view of anticipated fractures) Pregnant patients

Design outcomes

Primary

MeasureTime frame
The incidence of allogenic blood transfusions required in the perioperative periodTimepoint: from enrolment till post-operative day 1

Secondary

MeasureTime frame
Adverse reactionsTimepoint: During Intravenous Iron administration and during surgery;The changes in hemoglobin concentration from the baseline (at enrolment) between the two groups at two different time pointsTimepoint: on the day before surgery and on post-operative day 1;The serum ferritin levels and the percentage transferrin saturation between the two groups at two different time points [as compared to baseline]Timepoint: day before surgery and on post-operative day 1;The total number of units of packed red blood cell transfusions required in the perioperative periodTimepoint: from enrolment till post-operative day 1

Countries

India

Contacts

Public ContactDr Manyata Nema

Department of Onco-Anaesthesia and Palliative Medicine, Dr. BRAIRCH, AIIMS, New Delhi

sachidadr@yahoo.co.in9968436042

Outcome results

None listed

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