| CTRI Number |
CTRI/2020/12/029984 [Registered on: 23/12/2020] Trial Registered Prospectively |
| Last Modified On: |
21/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
STUDY OF CORRELATION BETWEEN MARKERS OF COAGULATION AND CLINICAL SEVERITY IN COVID 19 |
|
Scientific Title of Study
|
A STUDY OF COAGULATION MARKERS AND THEIR CORRELATION WITH CLINICAL SEVERITY IN COVID 19 ILNESS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AKASH J JANI |
| Designation |
Resident Doctor |
| Affiliation |
Smt NHL Municipal Medical College |
| Address |
Department of medicine, first floor, Sardar Vallabhbhai Patel Institute
of Medical Science and Research (SVPIMSR), Ellisbridge,
Ahmedabad,
Gujarat-380006
Ahmadabad
GUJARAT
380006
India |
| Phone |
8460706921 |
| Fax |
|
| Email |
akash.jani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AKASH J JANI |
| Designation |
Resident Doctor |
| Affiliation |
Smt NHL Municipal Medical College |
| Address |
Department of medicine, first floor, Sardar Vallabhbhai Patel Institute
of Medical Science and Research (SVPIMSR), Ellisbridge,
Ahmedabad,
Gujarat-380006
Ahmadabad
GUJARAT
380006
India |
| Phone |
8460706921 |
| Fax |
|
| Email |
akash.jani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PALTIAL PALAT |
| Designation |
Associate Professor |
| Affiliation |
Smt. NHL Municipal Medical College |
| Address |
Department of medicine, first floor, Sardar Vallabhbhai Patel Institute
of Medical Science and Research (SVPIMSR), Ellisbridge,
Ahmedabad,
Gujarat-380006
Ahmadabad
GUJARAT
380006
India |
| Phone |
9979886750 |
| Fax |
|
| Email |
paltialnpalat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Vallabhbhai Patel Institute
of Medical Science and Research (SVPIMSR) |
|
|
Primary Sponsor
|
| Name |
Smt NHL Municipal Medical College |
| Address |
Smt. NHL Municipal Medical College
Ellisbridge
Ahmedabad-380006 |
| Type of Sponsor |
Other [Municipal Medical College] |
|
|
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 AKASH J JANI |
Sardar Vallabhbhai Patel Institute of Medical Science and Research (SVPIMSR) |
Department of Medicine
First Floor, Sardar
Vallabhbhai Patel
Institute of Medical
Science and Research
(SVPIMSR) Ellis Bridge
Ahmedabad-380006
Ahmadabad GUJARAT
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
8460706921
akash.jani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD, SMT NHL MUNICIPAL MEDICAL COLLEGE, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inpatients in General Medicine with a established diagnosis of COVID 19 infection( Laboratory confirmed )
Patients with abnormal coagulation markers Patients of age >18 years
|
|
| ExclusionCriteria |
| Details |
Patients with proven others causes of coagulopathy - VTE, DVT, Recent Surgery/Trauma, Pregnancy, Cancer
Patients already on anticoagulant therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
In-hospital stay (Duration and Type of stay: ICU or Ward)
|
At Baseline, Every 3rd Day till Discharge/Death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Morbidity (PE, DVT,Stroke,etc)
Mortality
|
At Baseline, Every 3rd Day till Discharge/Death |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/12/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet decided about publication. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Design: Cross sectional, prospective, observational study Study Duration: 24 months after IRB/CTRI approval Hypothesis: - In patients with COVID-19, there is a progression from adaptive hemostasis to pathologically induced Disseminated Intravascular Coagulopathy (DIC) to multi organ failure.
- Hence, coagulation profile in Covid 19 disease could be a significant marker to predict the clinical severity of disease and hence the overall outcome of patients from the disease.
Aims and Objectives: - Studying the coagulation markers and their progression in COVID-19 .
- Correlation of coagulation markers with the clinical severity of COVID-19
- Outcome of patients with elevated coagulation markers in terms of:
- In-hospital stay (Duration and Type of stay: ICU or Ward)
- Morbidity (PE, DVT,Stroke,etc)
- Mortality
|