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CTRI Number  CTRI/2021/08/035510 [Registered on: 06/08/2021] Trial Registered Prospectively
Last Modified On: 05/08/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Analyzing the utility of blood coagulation test to diagnose blood clot lysis 
Scientific Title of Study   Diagnosing and Categorizing Acquired Fibrinolysis using Global Hemostatic Assays. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ganesh Mohan 
Designation  Associate Professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Immunohematology and Blood Transfusion, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Manipal,

Udupi
KARNATAKA
576104
India 
Phone  9539788828  
Fax    
Email  drganeshmohan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ganesh Mohan 
Designation  Associate Professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Immunohematology and Blood Transfusion, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Manipal,


KARNATAKA
576104
India 
Phone  9539788828  
Fax    
Email  drganeshmohan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ganesh Mohan 
Designation  Associate Professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Immunohematology and Blood Transfusion, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Manipal,


KARNATAKA
576104
India 
Phone  9539788828  
Fax    
Email  drganeshmohan@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 
 
Primary Sponsor  
Name  NIL 
Address  Not Applicable 
Type of Sponsor  Other [NIL] 
 
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 Ganesh Mohan  Immunohematology Lab, Blood Centre, Kasturba Medical College Manipal.  Kasturba Medical College Manipal, Madhav Nagar, Manipal, Udupi, 576104
Udupi
KARNATAKA 
08202922331

drganeshmohan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical COllege and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D689||Coagulation defect, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All TEG request for Citrated Kaolin TEG test 
 
ExclusionCriteria 
Details  Patients diagnosed with sepsis (ongoing project, so to avoid data duplication), age less than 18 years, Death within 48 hours, Patients who were discharged against medical advice, patients with a history of ongoing thrombolysis therapy, patients on anti fibrinolytic drugs and other modalities of TEG.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
categorizing the diagnosed fibrinolytic activity into primary and secondary based on TEG algorithm. Sensitivity and Area under the curve for Thrombin generation assay in diagnosing fibrinolysis activity compared to thromboelastogram. Correlation between TEG and TGA paramters as per manufacturer algorithm.  Primary outcome - 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
clinical correlation with the diagnosis of primary and secondary fibrinolysis. Correlation of laboratory tests and TEG parameters. Management given to the patient and clinical outcome of patients  24 months 
 
Target Sample Size   Total Sample Size="476"
Sample Size from India="476" 
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)   10/08/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Thrombelastogram or Thrombelastography (TEG) has been in used as point of care test in the management of hemorrhagic shock and to monitor patients during surgeries. With the help of Viscoelastic test (Thromelastography / Rotational thrombelastometry) the protocol based massive transfusion has been evolving into patient based individualized massive transfusion. However, the evidence on the utility of TEG in diagnosing fibrinolysis activity is very limited in international level. To take it further, TEG can be utilized in identifying and categorizing it into primary or secondary fibrinolysis based on the manufacture’s protocol. The pathophysiology and hence the management of primary fibrinolysis is entirely different from secondary fibrinolysis as seen in trauma and sepsis. Even though there are various standardized tests to monitor the enzymatic coagulation part of the hemostasis, like PT and aPTT, the investigations to diagnose fibrinolysis activity are not so well developed compared to others. Diagnosing fibrinolysis and categorizing them into primary and secondary is gaining international attention because of the renewed classification of some of the coagulopathies based on fibrinolysis activity and type.

 
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