| CTRI Number |
CTRI/2023/04/051689 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
11/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Venous thromboembolism (VTE ) and cardiopulmonary involvement in Covid 19 patients – An institutional clinical study |
|
Scientific Title of Study
|
Venous thromboembolism (VTE) and cardiopulmonary involvement in covid-19 patients - An Institutional Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Viveka Kumar |
| Designation |
Director Cath lab |
| Affiliation |
Max Superspeciality Hospital Department of Cardiology New Delhi |
| Address |
room number 3 ground floor cardiac division Max Superspeciality Hospital
2 press enclave road
Saket New Delhi 110017
room number 3 ground floor cardiac division
Max Superspeciality Hospital Department of Cardiology New Delhi
South
DELHI
110017
India |
| Phone |
|
| Fax |
|
| Email |
viveka.kumar@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sangeeta Dhir |
| Designation |
Consultant Dentistry & Clinical Research |
| Affiliation |
Max Superspeciality Hospital Department of dentistry and clinical research New Delhi |
| Address |
Max Superspeciality Hospital
2 press enclave road
Saket New Delhi 110017
room number 3 ground floor cardiac division
Max Superspeciality Hospital Department of dentistry and clinical research New Delhi
South
DELHI
110017
India |
| Phone |
|
| Fax |
|
| Email |
sangeetadhir@smilinedental.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Sangeeta Dhir |
| Designation |
Consultant Dentistry & Clinical Research |
| Affiliation |
Max Superspeciality Hospital Department of dentistry and clinical research New Delhi |
| Address |
Max Superspeciality Hospital
2 press enclave road
Saket New Delhi 110017
room number 3 , cardiac division Max Superspeciality Hospital Department of dentistry and clinical research New Delhi
South
DELHI
110017
India |
| Phone |
|
| Fax |
|
| Email |
sangeetadhir@smilinedental.com |
|
|
Source of Monetary or Material Support
|
| Max Superspeciality Hospital
Trial will be undertaken at the hospital . Hospital will bear the monetary / material support as required in this study |
|
|
Primary Sponsor
|
| Name |
Max Superspeciality Hospital |
| Address |
2 PRESS ENCLAV ROAD SAKET NEW DELHI |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Prof DR SANGEETA DHIR |
Max Superspeciality Hospital |
room number 3 cardiac divisison 2 Press Enclave Road Saket
New Delhi
South
DELHI |
91-9818181971
sangeetadhir@smilinedental.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe DEVKI DEVI FOUNDATION |
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, (2) 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 |
40.00 Year(s) |
| Gender |
Both |
| Details |
patients were divided into two groups :
<18- 40 years and > 40 years and above |
|
| ExclusionCriteria |
| Details |
non covid patients |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To understand prevalence of Pulmonary embolism , Right ventricular dysfunction dysfunction and Deep vein thrombosis in patients with COVID-19. |
At the time of analysis of patient data |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To understand the correlation of PE , DVT and RV dysfunction in covid patients
• To understand the correlation of PE , patients age and hospitalization in covid patients
|
At the time of analysis of the patient data |
|
|
Target Sample Size
|
Total Sample Size="505"
Sample Size from India="505"
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)
|
14/05/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 30-01-2023 and end date provided 28-05-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Study Hypothesis : Patients suffering from covid 19 are at high risk of venous thromboembolism ( i.e pulmonary embolism and deep vein thrombosis )
Based on the published literature higher incidence and risk of pulmonary embolism has been reported in covid 19 patients. We intend to undertake this retrospective study in the covid 19 patients who were admitted to the hospital during covid 1st and 2 nd wave in India. Patient data will be retrieved from the hospital electronic records based on the selection criteria. Parameters to be assesed will be : d-dimer, CTSS scoring , DVT , RVD and and nature of hospitalization. |