FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/02/007864 [Registered on: 14/02/2017] Trial Registered Prospectively
Last Modified On: 20/05/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to determine if a new method of testing blood clotting (thromboelastography) can help to predict how much blood transfusion is required in liver disease patients with variceal bleeding. 
Scientific Title of Study   Thromboelastography guided blood product transfusion in cirrhosis patients with acute variceal bleeding: a Randomized Controlled Trial 
Trial Acronym  TEGVAR 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalimar 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no-3111, Teaching Block, Deptt of Gastroenterology All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  9868397211  
Fax    
Email  drshalimar@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shalimar 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no-3111, Teaching Block, Deptt of Gastroenterology AIIMS, New Delhi


DELHI
110029
India 
Phone  9868397211  
Fax    
Email  drshalimar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shalimar 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no-3111, Teaching Block, Deptt of Gastroenterology AIIMS, New Delhi


DELHI
110029
India 
Phone  9868397211  
Fax    
Email  drshalimar@yahoo.com  
 
Source of Monetary or Material Support  
None, part of standard protocol for patient management 
 
Primary Sponsor  
Name  Department of Gastroenterology AIIMS New Delhi 
Address  Ansari Nagar, New Delhi 
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 shalimar  All India Institute of Medical Sciences, New Delhi  AB2 ward, second floor, Department of Gastroenterology All India Institute of Medical Sciences, New Delhi-110029
South
DELHI 		 9868397211

drshalimar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cirrhosis with Variceal bleeding,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Standard therapy arm  FFP and Platelets transfusion as per standard guidelines 
Comparator Agent  TEG therapy arm  FFP and Platelets transfusion without TEG guided 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Cirrhosis with acute variceal bleeding
2. Age between 18-65 years
3. Willing to participate in the study
 
 
ExclusionCriteria 
Details  1. Variceal bleeding secondary to causes other than cirrhosis. eg, extrahepatic venous obstruction, hepatic venous outflow track obstruction
2. Patients with malignancy/disseminated intravascular coagulation (DIC)/known coagulopathic disorder (haemophilia) apart from cirrhosis.
3. History of intake of platelets inhibitors (eg, aspirin, clopidogrel) and drugs affecting coagulation cascade (eg, vitamin K anatagonists) within past 7 days
4. Pregnant women and those on oral contraceptives
5. Patients with chronic renal failure
6. History of underlying hypercoagulable/ hypocoagulable states eg. paroxysmal nocturnal hemoglobunuria (PNH), polycythemia vera etc
7. Patients receiving blood products (fresh frozen plasma and platelet prior to thromboelastography)
8. Patients with shock
9. Sepsis
10. Acute on chronic liver failure
11. Hepatorenal syndrome
12. Hepatic encephalopathy
13. Contraindication to endoscopy
14. Not willing to provide consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in the requirement of blood products between the two groups.   24 hours, 120 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. Control of variceal bleeding at 24 hours and 5 days.
2. Rebleeding and mortality at 6 weeks.
 		 1. Control of variceal bleeding at 24 hours and 5 days.
2. Rebleeding and mortality at 6 weeks.
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2017 
Date of Study Completion (India) 29/12/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Our aims of the study is to assess the role of TEG in guiding transfusion of blood products in patients with variceal UGI bleed. Presently patients with UGI bleed are transfused platelets and fresh frozen plasma prophylactically. The results might be will be useful in changing the management protocols for UGI bleed. We expect that TEG based therapy will reduce the need for prophylactic transfusion of blood products.  
Close