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CTRI Number  CTRI/2024/11/077013 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   An observational study to find the incidence and risk factors of central venous catheter associated deep vein thrombosis in ICU patients 
Scientific Title of Study   A Prospective Observational Study Of The Incidence and Risk Factors Of Catheter Associated 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  Anjusha TV 
Designation  critical care medicine resident  
Affiliation  Artemis hospital 
Address  Department of Critical Care Medicine Artemis Hospital

Gurgaon
HARYANA
122001
India 
Phone  8848225926  
Fax    
Email  anjushaashokan93@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anjusha TV 
Designation  critical care medicine resident  
Affiliation  Artemis hospital 
Address  Department of Critical Care Medicine Artemis Hospital

Gurgaon
HARYANA
122001
India 
Phone  8848225926  
Fax    
Email  anjushaashokan93@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anjusha TV 
Designation  critical care medicine resident  
Affiliation  Artemis hospital 
Address  Department of Critical Care Medicine Artemis Hospital

Gurgaon
HARYANA
122001
India 
Phone  8848225926  
Fax    
Email  anjushaashokan93@gmail.com  
 
Source of Monetary or Material Support  
Artemis hospital sector 51, Gurgaon, Haryana India 122001 
 
Primary Sponsor  
Name  Artemis Hospital 
Address  Artemis hospital Sector 51 Gurugram, Haryana India 122001 
Type of Sponsor  Private hospital/clinic 
 
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 Jeetendra Sharma  ARTEMIS HOSPITAL  Department of Critical care medicine ICU-2
Gurgaon
HARYANA 
7042118485

drjeetendrasharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Artemis health Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I824||Acute embolism and thrombosis of deep veins of lower extremity, (2) ICD-10 Condition: I82C||Embolism and thrombosis of internal jugular vein,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1) Patients with IJV or Femoral central venous catheter placement (Central venous line, dialysis catheter, introducer sheath) 
 
ExclusionCriteria 
Details  1) Patient refusal to participate in the study
2) Patients who are less than 18 years old
3) Discharge / LAMA/ demise before 72 hours
4) Pre-existing haematological thrombotic disorder
5) Patients with active diagnosis of DVT/ pulmonary embolism
6) Any reason wherein USG examination not possible
7) Repeat catheter insertion in the same vein.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
incidence and risk factors of central venous catheter associated deep vein thrombosis.  incidence of thrombosis will be assessed at day 3,5,7,10 and 15 
 
Secondary Outcome  
Outcome  TimePoints 
1.incidence of patient related risk factors.
2.incidence of catheter related risk factors.
3. Occurrence of deep vein thrombosis with respect to time frame
4.incidence of deep vein thrombosis with respect to thromboprophylaxis.
5. Proportion of symptomatic & asymptomatic cases

 
1.incidence of patient & catheter related risk factors will be assessed after 28 days or till patient stay in hospital
3.Occurrence of deep vein thrombosis with respect to time frame on day 3,5,7,10,15 & 28
4.incidence of deep vein thrombosis with respect to thromboprophylaxis on day 3,5,7,10,15
5.Proportion of symptomatic & asymptomatic cases will be assessed till day 28 of hospital stay/discharge/demise

 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   26/11/2024 
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 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  

Central venous catheters are inserted in critically ill patients for various purposes. But they are also associated with complications such as catheter associated deep vein thrombosis which if kept undiagnosed or untreated, can lead to pulmonary embolism and increased mortality. The following study hypothesise that there is significant incidence of central line associated deep vein thrombosis in Intensive Care Unit (ICU) patients. Routine screening for the same can help in early diagnosis of thrombosis and prevent deterioration.

The primary objectives of this study are to determine the incidence of catheter associated deep vein thrombosis and to identify the risk factors associated with development of thrombosis. Total of 120 patients with Internal Jugular Vein (IJV) or Femoral venous line placement will be included in the study for evaluation. Catheters removed within 72 hours, patient discharge / demise in 72 hours will be excluded.  Assessment for thrombosis will be done using doppler ultrasound on IJV or femoral vein based on the site of catheter inserted. Ultrasound assessment will be carried out on day 3,5,7,10 and 15 of catheter insertion and the observations will be tabulated irrespective of catheter in situ or removed. If patient develops any symptoms, ultrasound assessment will be done irrespective of the timeframe. Statistical analysis of the data will be performed to determine the incidence, incidence rate, risk factors related to patients and catheter. This study anticipates early detection of asymptomatic thrombosis by routine ultrasound screening. Diagnosis of thrombosis might help in treatment for the same and improved patient care.

 
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