Analyzing the utility of blood coagulation test to diagnose blood clot lysis

Not yet recruiting

Conditions: Coagulation defect, unspecified,

Registration Number: CTRI/2021/08/035510

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 manufactureâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 476

Inclusion Criteria

All TEG request for Citrated Kaolin TEG test.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Immunohematology Lab, Blood Centre, Kasturba Medical College Manipal.
🇮🇳
Udupi, KARNATAKA, India
Immunohematology Lab, Blood Centre, Kasturba Medical College Manipal.
🇮🇳Udupi, KARNATAKA, India
Dr Ganesh Mohan
Principal investigator
08202922331
drganeshmohan@gmail.com