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CTRI Number  CTRI/2025/05/087624 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 22/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   To study the effect of fibrinogen(a protein that helps to reduce bleeding) in patients undergoing cardiac surgery 
Scientific Title of Study   Effect of fibrinogen concentrate administration on perioperative bleeding in patients undergoing complex cardiac surgery-A prospective, comparative study 
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 Christy Pius Kaliyadan 
Designation  DrNB Trainee 
Affiliation  Medanta the Medicity 
Address  Department of cardiac Anesthesia 1st floor Medanta the Medicity Sector 38 Gurgaon

Gurgaon
HARYANA
122001
India 
Phone  9539747439  
Fax    
Email  christy.pious725@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajmer Singh 
Designation  Director of cardiac anaesthesia 
Affiliation  Medanta the Medicity 
Address  Department of cardiac Anesthesia 1st floor Medanta the Medicity Sector 38 Gurgaon

Gurgaon
HARYANA
122001
India 
Phone  9539747439  
Fax    
Email  ajmersingh@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Christy Pius Kaliyadan 
Designation  DrNB Trainee 
Affiliation  Medanta the Medicity 
Address  Department of cardiac Anesthesia 1st floor Medanta the Medicity Sector 38 Gurgaon

Gurgaon
HARYANA
122001
India 
Phone  9539747439  
Fax    
Email  christy.pious725@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Medanta The Medicity  
Address  Medanta The Medicity Sector 38 gurugram Haryana 122001 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Christy Pius Kaliyadan  Medanta The Medicity  Medanta the Medicity sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA 		 09539747439

christy.pious725@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medanta Institutional Ethics Committee   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  Fibrinogen Concentrate   Fibrinogen Concentrate is a protein synthesized in liver that helps in clotting. In cardiac surgery it reduces bleeding improves coagulation reduces transfusion requirements and risk of post operative complications.Approximately 2 vials containing 1g each of fibrinogen is necessary for this trial.The dose of fibrinogen is calculated by a formula (target fibrinogen level - measured fibrinogen levels)/correction factor 
Comparator Agent  Placebo  Normal Saline is given as a placebo to the control group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients undergoing Re-do surgeries, valve replacement and repair surgeries and surgeries involving aorta  
 
ExclusionCriteria 
Details  Refusal to participate
Emergency Surgery
Known congential or acquired coaguloapthy
Pre-operative with hematocrit less than 35
Known severe fibrinogen deficiency
Known prior history of anaphylactic reaction to fibrinogen containing products  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Less post operative 12 hour blood loss
 		 12 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Lesser requirement of blood and blood products transfusion
and higher post operative fibrinogen levels  		 12 months 
 
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)   08/06/2025 
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)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [christy.pious725@gmail.com].

  6. For how long will this data be available start date provided 12-05-2026 and end date provided 30-04-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NA
Brief Summary   This study will assess the effect of fibrinogen concentrate on post operative 12 hour blood loss and requirement of blood and blood product transfusion in patients undergoing complex cardiac surgery.  
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