| CTRI Number |
CTRI/2025/12/098580 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic accuracy |
| Study Design |
Other |
|
Public Title of Study
|
Using Bedside Ultrasound to Improve Early detection of Blood Clots in the ICU patients |
|
Scientific Title of Study
|
To evaluate diagnostic accuracy of wells clinical probability, bedside pocus, and selective d-dimer for early diagnosis of deep vein thrombosis in ICU 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 |
Dr Ruchi Gupta |
| Designation |
Professor and Head |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Main ICU, Sri Guru Ram Das Institute of Medical Sciences and Research
Amritsar
PUNJAB
143001
India
Amritsar PUNJAB 143001 India |
| Phone |
9814320805 |
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sachreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Main ICU, Sri Guru Ram Das Institute of Medical Sciences and Research
Amritsar
PUNJAB
143001
India
Amritsar PUNJAB 143001 India |
| Phone |
7888922797 |
| Fax |
|
| Email |
sachreetdr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Harshdeep Singh Dhingra |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Main ICU, Sri Guru Ram Das Institute of Medical Sciences and Research
Amritsar
PUNJAB
143001
India
Amritsar PUNJAB 143001 India |
| Phone |
6283711029 |
| Fax |
|
| Email |
harshdeep051998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Gur Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab. 143001 |
|
|
Primary Sponsor
|
| Name |
SGRD |
| Address |
Main ICU, Sri Guru Ram Das institute of medical Sciences and Research, Amritsar, 143001 |
| 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 Sachreet kaur |
Intensive Care Unit |
Main ICU, Sri Guru Ram Das Institute of Medical Sciences and Research
Amritsar
PUNJAB
143001
India
Amritsar PUNJAB |
78889 22797
sachreetdr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. ICU patients who are expected to stay more than 72 hours
2. Consent obtained from patient |
|
| ExclusionCriteria |
| Details |
1.Pregnant women
2. Known DVT in the same limb within the previous 3 months.
4. Limb conditions that make POCUS technically impossible or unsafe (e.g.,extensive open wounds or dressings preventing venous compression, major burns, external fixation on the affected limb). |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Detection of early deep vein thrombosis in ICU patients using wells probability score, D-dimer and doppler ultrasound. |
follow up will be done on 2nd, 3rd, 7th day from the day of admission in ICU. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Nil |
|
|
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)
|
25/12/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Introduction: Early and accurate detection of deep vein thrombosis (DVT) is critical in ICU patients, who are at high risk due to immobility and complex comorbidities. Reliance on clinical features alone is often insufficient, and combining diagnostic modalities such as Wells Clinical Probability scoring, point-of-care ultrasound (POCUS), and selective D-dimer testing may optimize patient triage and reduce unnecessary imaging. Aims and Objectives: This study aims to assess the diagnostic accuracy and efficiency of a combined approach of wells score, bedside POCUS, and selective D-dimer measurement for early DVT detection in adult ICU patients. Methodology: Adult patients admitted to the ICU, without known DVT at admission, will be prospectively evaluated. Initial risk stratification will be performed of wells Clinical Probability scoring. Bedside POCUS will be used for lower limb venous assessment in moderate/high-risk patients or those with positive D-dimer results. Selective D-dimer testing will help determine the need for further ultrasound in low-risk cases. Diagnostic outcomes will be validated against standard duplex ultrasound findings and clinical follow-up. Outcome: This study will determine whether a combined strategy can safely and efficiently identify early DVT in ICU patients, potentially reducing the need for comprehensive imaging, lowering costs, and allowing for timely intervention to prevent complications such as pulmonary embolism. |