A study on the Effect of intravenous iron therapy to treat anemia in cancer patients undergoing major surgeries
Not Applicable
Completed
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2023/07/055649
- Lead Sponsor
- Basavatarakam Indo American Cancer Hospital & Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 31
Inclusion Criteria
1. Major elective abdominal surgeries
2. ASA I-III
3. Hemoglobin concentration less than 8.5 g/d
Exclusion Criteria
1. Laboratory test confirmed iron deficiency: serum ferritin >30mcg/L alone or serum
ferritin 30-100mcg/L with TSAT >20%
2. Other known causes of anaemia apart from iron deficiency
3. chronic renal failure on dialysis
4. Chronic liver failure
5. Presence of iron overload ; known hemochromatosis / Thalassemias
6. Known hypersensitivity towards Ferric carboxymaltose
7. Participation in another ongoing other interventional clinical trial(s)
8. Patients undergoing emergency surgeries
9. Significant Coronary artery disease
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The efficacy of IV iron administration to improve preoperative hemoglobin concentrationTimepoint: to evaluate hemoglobin levels one day prior to surgery & on postoperative days 1 & 2.
- Secondary Outcome Measures
Name Time Method 1. To determine the effect of preoperative intravenous iron supplementation therapy on the <br/ ><br>need for perioperative blood transfusions. <br/ ><br>2. To determine the effect of preoperative IV iron supplementation on serum phosphate <br/ ><br>levels a day prior to the surgeryTimepoint: requirement of blood transfusion in the postoperative period & to evaluate phosphate levels one day prior to surgery & on post operative day 3