| CTRI Number |
CTRI/2025/07/091005 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to assess the blood clotting disorders on patients admitted in intensive care unit. |
|
Scientific Title of Study
|
An observational study on assessment of coagulation abnormalities in critically ill patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakshaya shree G |
| Designation |
msc critical care technology |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
Department of critical care medicine Ramachandra Medical college Trunk Road Sri Ramachandra nagar porur chennai 600116
Department of critical care medicine Ramachandra Medical college Trunk Road Sri Ramachandra nagar porur chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
8015833554 |
| Fax |
|
| Email |
rakshu242003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Baby Sailaja K |
| Designation |
Associate Professor |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
department of critical care medicine Ramachandra Medical college trunk road Sri Ramachandra nagar porur chennai 600116
Department of critical care medicine,Ramachandra Medical college trunk road Sri Ramachandra nagar porur chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9600159482 |
| Fax |
|
| Email |
sailajaroop@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Baby Sailaja K |
| Designation |
Associate Professor |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
department of critical care medicine Ramachandra Medical college trunk road Sri Ramachandra nagar porur chennai 600116
Department of critical care medicine,Ramachandra Medical college trunk road Sri Ramachandra nagar porur chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9600159482 |
| Fax |
|
| Email |
sailajaroop@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
department of critical care medicine Ramachandra Medical college trunk road Sri Ramachandra nagar porur chennai 600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Baby sailaja K |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Department of Critical Care Medicine
Porur chennai 600116
chennai
Chennai
TAMIL NADU |
9600159482
sailajaroop@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D65||Disseminated intravascular coagulation [defibrination syndrome], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Invasive procedure and Significant trauma |
|
| ExclusionCriteria |
| Details |
Patients with known stable chronic thrombocytopenia and patients with isolated vitamin K deficiency |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality in ICU patients. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need for interventions based on the abnormality. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
04/08/2025 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |