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
|
|
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
|
|
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. |