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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: D689||Coagulation defect, unspecified, |
|
Intervention / Comparator Agent
|
|
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. |