| 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
|
|
|
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
|
|
|
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. |