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CTRI Number  CTRI/2025/11/097145 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 10/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Biomarkers for bleeding, thrombosis and infection in patients on veno-arterial extracorporeal membrane oxygenation  
Scientific Title of Study   Relationship between the dynamic trajectory of biomarkers for bleeding, thrombosis and infection in patients on veno-arterial extracorporeal membrane oxygenation and their causal association with ICU mortality 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Khushboo Mehta 
Designation  Senior resident 
Affiliation  All India Institute of Medical Sciences New Delhii 
Address  Department of Cardiac Anaesthesia and Critical Care
All India Institute of Medical Sciences Ansari Nagar New Delhi 110029
South
DELHI
110029
India 
Phone  8128529063  
Fax    
Email  mehta.khushboo1994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Khushboo Mehta 
Designation  Senior resident 
Affiliation  All India Institute of Medical Sciences New Delhii 
Address  Department of Cardiac Anaesthesia and Critical Care
All India Institute of Medical Sciences Ansari Nagar New Delhi 110029
South
DELHI
110029
India 
Phone  8128529063  
Fax    
Email  mehta.khushboo1994@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Poonam Malhotra Kapoor 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences New Delhii 
Address  Department of Cardiac Anaesthesia and Critical Care
All India Institute of Medical Sciences Ansari Nagar New Delhi 110029
South
DELHI
110029
India 
Phone  997100074  
Fax    
Email  drpoonamaiims@gmail.com  
 
Source of Monetary or Material Support  
Journal of Cardiac Critical Care – The Simulation Society Research fund E-969, Chittranjan Park, New Delhi, India - -110019  
 
Primary Sponsor  
Name  Journal of Cardiac Critical Care The Simulation Society Research fund  
Address  E-969, Chittranjan Park, New Delhi, India - -110019 
Type of Sponsor  Other [Journal of Cardiac Critical Care – The Simulation Society Research fund ] 
 
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 Khushboo Mehta  All India Institute of Medical Sciences, New Delhi  Department of Cardiac Anaesthesia and Critical Care, Cardiothoracic and Neurosciences Centre
New Delhi
DELHI 
8128529063

mehta.khushboo1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I998||Other disorder of circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biomarkers ROTEM parameters, Platelet reactivity, D Dimer, Fibrinogen, Tumor Necrosis Factor alpha, High sensitivity C Reactive Protein, Procalcitonin, Interleukin 6, Neutrophil Lymphocyte ratio, Lactate clearance   Levels of these biomarkers will be assessed at baseline followed by 24h followed by 72h and at 7 days if the patient survives using ROTEM delta Verify Now and Lamuno Plus machines. 
Comparator Agent  Standard Coagulation profile including Prothrombin time activated partial thromboplastin time international normalised ratio Total leucocyte count arterial lactates  Levels of these biomarkers will be assessed at baseline followed by 24h followed by 72h and at 7 days if the patient survives. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients from age birth till 50 years
Either gender
Undergoing elective cardiac surgery on cardiopulmonary bypass requiring integrated VA ECMO
 
 
ExclusionCriteria 
Details  Emergency cardiac surgeries or Re-do surgeries
ECMO duration less than 24h
Pre-existing coagulopathies
Pre-existing liver or kidney or neurological dysfunction
Pre-existing systemic infection
Errors in detection of biomarkers or incomplete detection of biomarkers needed for analysis
Lack of consent from the patient

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mortality on VA-ECMO in ICU and its correlation to the levels of various biomarker levels.  Samples will be collected at baseline followed by 24h followed by 72h and at 7 days after ECMO initiation depending on the survival 
 
Secondary Outcome  
Outcome  TimePoints 
Drain output in first 24 hours in ICU  at first 24h 
Blood transfusion requirement on ECMO in ICU  Total blood and blood product transfusion from beginning till weaning or mortality on ECMO 
Duration of mechanical ventilation in ICU  From initiation of ECMO till weaning from mechanical ventilation 
Antibiotic requirement and incidence of sepsis  From ECMO initiation till weaning from ECMO 
Vasoactive Inotropic Score  Calculated at baseline followed by 24h followed by 72h and at 7 days after ECMO initiation depending on the survival 
Correlation between biomarkers for bleeding, thrombosis and infection.   Samples will be collected at baseline followed by 24h followed by 72h and at 7 days after ECMO initiation depending on the survival 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   21/11/2025 
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="2"
Months="6"
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  

Venoarterial ECMO (VA-ECMO) is a subset in which both mechanical circulatory support as well as gas exchange functions are taken over by the ECMO machine to provide a bridge for patients in severe cardiorespiratory failure. However, it is not without complications. The three most common and fatal complications encountered in ECMO patients are- Bleeding, thrombosis and infection. Hence, to monitor the progress of patients on ECMO we need to assess for these complications from time to time which can be done by monitoring the levels of various biomarkers. Certain tests are routinely performed at our institute to monitor ECMO patients. However, till now no research is available to show the utility of point-of-care biomarker tests for bleeding, thrombosis and infection and how the results of these can be correlated with each other and also to predict the outcome of patients on ECMO. Most of the data available till now is from retrospective, observational studies with very little literature available from Indian population. Most studies also focus on a single outcome measure and do not study the correlation among various biomarkers for bleeding/thrombosis/infection and their causal association with mortality. Thus, we wish to undertake this research to study the correlation between biomarkers for bleeding, thrombosis and infection in patients on VA-ECMO post cardiac surgery in the ICU and their causal association with the final outcome of the patients in ICU. Also, we wish to develop an AIIMS scoring for 5 best biomarkers for prognostic screening in VA-ECMO patients. 

 
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