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CTRI Number  CTRI/2025/05/087381 [Registered on: 22/05/2025] Trial Registered Prospectively
Last Modified On: 21/05/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   How Effective Is Iron drip in Helping Cancer Surgery Patients Recover? 
Scientific Title of Study   AN AUDIT TO EVALUATE THE EFFECTIVENESS OF INTRAVENOUS HEMATINICS THERAPY IN PERIOPERATIVE OUTCOMES IN MAJOR ABDOMINAL ONCOSURGERIES 
Trial Acronym  ANEMIA 
Secondary IDs if Any  
Secondary ID  Identifier 
901138_Protocol_V_2.0_dated_04.04.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Reshma Ambulkar 
Designation  Professor and Head 
Affiliation  Tata Memorial Centre  
Address  Department of Anesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar

Raigarh
MAHARASHTRA
410210
India 
Phone  410210  
Fax    
Email  rambulkar@hotmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Reshma Ambulkar 
Designation  Professor and Head 
Affiliation  Tata Memorial Centre  
Address  Department of Anesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar


MAHARASHTRA
410210
India 
Phone  410210  
Fax    
Email  rambulkar@hotmail.com   
 
Details of Contact Person
Public Query
 
Name  Reshma Ambulkar 
Designation  Professor and Head 
Affiliation  Tata Memorial Centre  
Address  Department of Anesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar


MAHARASHTRA
410210
India 
Phone  410210  
Fax    
Email  rambulkar@hotmail.com   
 
Source of Monetary or Material Support  
Department of Anesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai, MAHARASHTRA 410210 India  
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Department of Anesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai, MAHARASHTRA 410210 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Reshma Ambulkar  Advanced Centre for Treatment, Research and Education in Cancer(ACTREC)  Department of Anesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar
Raigarh
MAHARASHTRA 
9821790448

rambulkar@hotmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre Institutional Ethics Committee III   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Haemoglobin less than 12g/dl in females and less than 13g/dl in males
2.All elective major abdominal oncosurgeries (Upper and lower gastrointestinal surgeries, Hepatico-pancreatico-biliary surgeries, Urological and Gynaecological surgeries)
3.Patients over the age of 18 years
 
 
ExclusionCriteria 
Details  1.Emergency surgery
2.H/o allergy to parenteral iron preparations
3.Patients with recurrent or second primary cancer
4.Palliative surgery
5.Patients with chronic liver disease, chronic kidney disease, iron storage disorder, haematological malignancy and hemoglobinopathies
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increase in mean Hemoglobin value after preoperative intravenous therapy to treat anaemia  Hb at first visit, Preoperative Hb, Postoperative Hb 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study the effect of intravenous haematinics on the number of PRBC transfusions during and within 72 hours after surgery in comparison with patients without iron therapy
2.Incidence of anemia in patients undergoing major abdominal oncosurgeries
3.Percentage of anaemic patients who have undergone anemia workup and those who have received perioperative iron therapy
4.The mean time (in days) available for treatment of preoperative anemia: time from decision of surgery to detection of anemia and to date of surgery.
 
Hb at first visit, Preoperative Hb, Postoperative Hb 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Anemia, a condition where the blood lacks enough healthy red blood cells to carry oxygen, is common in cancer patients scheduled for major abdominal surgeries. It affects 30–60% of these patients and can lead to complications such as increased need for blood transfusions, delayed recovery, and longer hospital stays. Traditional treatments like oral iron supplements often fail to address this anemia effectively because cancer and related conditions interfere with how the body processes and uses iron.

This study aims to explore the use of intravenous (IV) iron therapy to treat anemia before surgery. Unlike oral supplements, IV iron bypasses the barriers caused by inflammation and allows for faster correction of anemia. By improving hemoglobin before surgery, we hope to reduce the need for blood transfusions during or after the operation, lower the risk of complications, and speed up recovery.

Over one year, we will monitor cancer patients undergoing elective abdominal surgeries at our hospital. We will examine how effective IV iron therapy is in improving hemoglobin levels, reducing blood transfusions, and ensuring better overall outcomes. This research is especially important in countries like India, where anemia is highly prevalent, and effective management could significantly improve peri-operative outcomes.

 
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