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CTRI Number  CTRI/2025/08/093022 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to evaluate outcomes in patients on blood thinner medications in major non cardiac surgery 
Scientific Title of Study   A prospective observational study on peri-operative management strategies and outcomes in patients on anti-platelet therapy in elective major non cardiac surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4831_version 1.0 dated 07.05.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijaya Patil 
Designation  Professor and Head 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819883535  
Fax    
Email  vijayappatil@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijaya Patil 
Designation  Professor and Head 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai


MAHARASHTRA
400012
India 
Phone  9819883535  
Fax    
Email  vijayappatil@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Simran Prusty 
Designation  Post Graduate Student 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9284329533  
Fax    
Email  simran.prusty@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital Dr E Borges Road Parel Mumbai 400012 India 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Department of Anesthesia Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai 400012, Maharashtra, 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 Vijaya Patil  Tata Memorial Hospital  Room no. 201, Department of Anesthesia Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital, Dr E Borges Road, Parel 400012
Mumbai
MAHARASHTRA 		 9819883535

vijayappatil@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee-II  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 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  All patients undergoing major surgery in main OTs in TMH under anaesthesia on anti platelet therapy. 
 
ExclusionCriteria 
Details  Patients undergoing procedures in any other locations like minor OTs, IR, MRI suites, etc 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To observe the number of patients on antiplatelet therapy undergoing major elective non cardiac surgery and their peri operative modifications in management.  6 hours post op- MI and arrhythmias
24 hours post op- MACE
72 hours post op- Stroke 
 
Secondary Outcome  
Outcome  TimePoints 
1. To record the number of patients referred to other centres, from surgical OPD without referring to TMH PAC and record their outcome.
2. To note the number of patients referred to other centres or advised alternate modality from PAC in TMH after discussion in HRJCs.
3. To observe the number of patients on antiplatelet therapy and peri operative major adverse cardiac events. 		 At PAC assessment 
4. To record perioperative blood loss and requirement for transfusion
5. To record perioperative hemodynamic instability requiring vasopressor/inotrope supports
 		 Until ICU discharge 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   25/08/2025 
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  

Coronary artery disease is the most common heart disease in Indian population. On an average every 1 in 20 adults of age 20 and above suffer from coronary artery disease at various levels of progression. About a quarter (24.8%) of deaths in India in 2010 were attributable to cardiovascular diseases. About 60,000 patients on an average in a year undergo CABG surgery in India. (1) About 5.5 lakh stents are being utilized annually in India on an average. (2)

Patients undergo one of the three paths in the management of coronary heart disease/high risk paitents based on complex scoring systems. Firstly, in patients who have significant comorbidities and have stable angina are medically managed with anti-platelet therapy, anti-anginal drugs, risk factor control and lifestyle modifications. Patients who have unstable angina, NSTEMI usually undergo a risk stratification using SYNTAX scoring and multi-disciplinary discussion among the cardiac team in hospitals and either undergo a CABG procedure or a PCI. Patients who have an Acute Coronary Syndrome come in an emergency situation and undergo PCI procedure.

Having said that, the anaesthetic implications of such patients in an elective non-cardiac surgery are huge and need to be dealt with great consideration. The risk-benefit consideration starts from the surgery OPD, then in PAC clinic and then one day prior to taking the patient on OT table.

We are conducting this study to know the number of patients on anti-platelet therapy, indication for starting them and other procedures they may have undergone. We will be also be recording the peri-operative outcomes of these patients using RCRI scores and post operative MACE.  
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