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Clinical Trials/CTRI/2025/07/091005
CTRI/2025/07/091005Not yet recruitingNot Applicable

An observational study on assessment of coagulation abnormalities in critically ill patients

Sri Ramachandra Institute of Higher Education and Research1 site in 1 country108 target enrollmentStarted: August 4, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
108
Locations
1
Primary Endpoint
Mortality in ICU patients.

Study Overview

Brief Summary

This observational study aims to evaluate the prevalence, types, and clinical significance of coagulation abnormalities in critically ill patients admitted to the Intensive Care Unit (ICU). Coagulation disturbances are common in ICU settings due to underlying conditions such as sepsis, liver dysfunction, trauma, and the effects of various therapeutic interventions. The study will involve systematic assessment of coagulation parameters including prothrombin time (PT), activated partial thromboplastin time (aPTT), platelet counts , D-dimer, fibrinogen levels and Thromboelastography (TEG) in ICU patients over a specified period. Correlation between coagulation abnormalities and clinical outcomes such as bleeding, thrombosis, length of ICU stay, and mortality will also be analyzed. The findings are expected to provide insights into the importance of routine coagulation monitoring and guide early intervention strategies to improve patient outcomes.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Invasive procedure and Significant trauma.

Exclusion Criteria

  • Patients with known stable chronic thrombocytopenia and patients with isolated vitamin K deficiency.

Outcomes

Primary Outcomes

Mortality in ICU patients.

Time Frame: 4 weeks

Secondary Outcomes

  • Need for interventions based on the abnormality.(4 weeks)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Rakshaya shree G

Sri ramachandra institute of higher education and research

Study Sites (1)

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