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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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