| CTRI Number |
CTRI/2025/12/098482 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective analysis of retrospectively collected data |
| Study Design |
Other |
|
Public Title of Study
|
A study to identify patients with anaemia before cancer surgery |
|
Scientific Title of Study
|
Retrospective study of prevalence of anaemia and impact of anaemia management in the perioperative period |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 5009_Version 1.1 dated 28.10.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vandana Agarwal |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia,Critical care and pain, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02241770004042 |
| Fax |
|
| Email |
vandanachaukar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Agarwal |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia,Critical care and pain, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02241770004042 |
| Fax |
|
| Email |
vandanachaukar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivanand |
| Designation |
Junior resident |
| Affiliation |
Tata memorial hospital Mumbai |
| Address |
Department of Anaesthesia, Crtical care and Pain Tata memorial hospital
Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7259846668 |
| Fax |
|
| Email |
22shivumalage@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,Critical care and pain, Tata Memorial Hospital, Parel, Mumbai 400012, India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr.E Borges Road,Parel,Mumbai
400012 |
| 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 Vandana Agarwal |
Tata Memorial Hospital |
Department of Anaesthesia, Critical Care,Pain,
Tata Memorial Hospital, Ernest Borges Road, Parel East, Mumbai-400012
Mumbai
MAHARASHTRA |
02241770004042
vandanachaukar@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital_Institutional Ethics Committee I |
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.Patients who visited the PAC for the planned diagnostic and therapeutic procedure.Only the index cases will be considered for this study |
|
| ExclusionCriteria |
| Details |
1. Patients age less than 18 years
2. Pregnant women
3. patients whom preoperative hemoglobin levels within 1 month are not available
4.More than 50 percent data cannot be retrieved from the electronic medical record |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To study the prevalence of preoperative anaemia in patients who visited the PAC (Pre anaesthesia Clinic) |
Over a period of a month from 1st January to 31st January 2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study current perioperative anaemia management startgies,such as detection and diagnosis of anaemia , preoperative anaemia correction and change in haemoglobin before the surgery
2.Intraopertive blood loos and blood transfusion rate
3. Predischarge haemoglobin and hematinic prescription |
Over a period of a month from 1st January to 31st January |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
15/12/2025 |
| 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
|
The purpose of this study is to study the prevalence of anemia in patients planned for elective cancer surgery at Tata Memorial Hospital. In addition, we will audit current anemia management strategies and their impact on patient’s hemoglobin before surgery, their course in the hospital, and at discharge. Patients who visited the pre-anesthesia clinic for surgical fitness from 1st January – 31st January 2025 will be included in this study. We will be collecting the data from the electronic medical record, prescription information, investigation, and pre-anesthesia clinic records. Since this is a retrospective study, no additional tests will be done. There will be no additional cost incurred. No reimbursement will be required/done for this study since there are no risks involved. Results of this study will help us understand the anemia burden before surgery in our patients. It will also give us insight regarding the effectiveness of anemia management strategies before surgery. This information will help in improving the care delivered to our patients in the future. Information will be available to the investigators and the institutional ethics committee |