FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/10/046692 [Registered on: 20/10/2022] Trial Registered Prospectively
Last Modified On: 06/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  		 A comparative study to evaluate the effect of two different doses (intravenously administered bolus vs iv bolus plus infusion) of tranexamic acid in reducing intraoperative blood loss in patients undergoing pancreaticobiliary surgeries. 
Scientific Title of Study   A comparative study to evaluate the effect of two different doses of tranexamic acid in reducing intraoperative bleeding in patients undergoing pancreaticobiliary surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deeksha Raj 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pain Medicine and Critical care, AIIMS New Delhi, Ansari Nagar

South
DELHI
110029
India 
Phone  8940530324  
Fax    
Email  rajdeeksha343@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kelika Prakash 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pain Medicine and Critical care, AIIMS New Delhi, Ansari Nagar

South
DELHI
110029
India 
Phone  9540947117  
Fax    
Email  kelika.prakash@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kelika Prakash 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pain Medicine and Critical care, AIIMS New Delhi, Ansari Nagar

South
DELHI
110029
India 
Phone  9540947117  
Fax    
Email  kelika.prakash@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Ansari Nagar, New Delhi, 110029 
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 
Deeksha Raj  All India Institute of Medical Sciences, New Delhi  Operation theatre, AB8, Department of Anaesthesiology, Pain Medicine and Critical care
South
DELHI 		 8940530324

rajdeeksha343@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  tranexamic acid bolus followed by tranexamic acid infusion  15 mg/kg tranexamic acid over 10 minutes will be given prior to surgical incision followed by tranexamic acid infusion of 1 mg/kg/hr for the duration of surgery 
Comparator Agent  tranexamic acid iv bolus followed by NS infusion  15 mg/kg tranexamic acid iv over 10 minutes will be given prior to surgical incision followed by NS infusion for the duration of surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I and II patients undergoing open pancreaticobiliary surgeries( including surgeries for tumors, obstruction, injusries of the pancreas and bile ducts eg. Whipple surgery, pancreatectomy, extended cholecystectomy) 
 
ExclusionCriteria 
Details  patients with known coagulopathy or thrombocytopenias, patients with history of stroke, , CAD or PVD , CKD or CLD, patients with history of DVT or thromboembolism, pregnant or lactating women, patients with preoperative Hb less than 10g/dl, patients undergoing major hepatic surgeries and patients having indwelling catheters( chemoports) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to compare intraoperative blood loss between two groups( tranexamic acid bolus vs tranexamic acid bolus plus infusion)  intraoperative blood loss will be assesed and patients will be followed up 12 hrly for the first 24 hrs then daily during their hospital stay 
 
Secondary Outcome  
Outcome  TimePoints 
number of units of intraoperative PRBC transfused, percentage change in hematocrit( preoperative vs postoperative), duration of hospital stay, 28 days mortality  patients will be followed up 12 hrly for the first 24 hrs then daily during their hospital stay 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/10/2022 
Date of Study Completion (India) 05/11/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Intraoperative blood loss is a major concern in abdominal surgeries. It increases the incidence of blood transfusion which caries the risk of transfusion associated complications like infections, transfusion related acute lung injury , transfusion associated circulatory overload , acute hemolytic reaction and severe allergic reaction. Additionally increased increased intraoperative blood loss leads to administration of iv fluids which in turn leads to gut edema, ileus and anastomotic leaks. Tranexamic acid is an antifibrinolytic agent which is used intraoperatively to treat and prevent excessive blood loss. the dose of tranexamic acid required to reduce blood loss in patients undergoing trauma, orthopedic, cardiac and obstetrics is established. though tranexamic acid is routinely used during major abdominal surgeries there is wide variation in doses used in various studies. in addition not many studies have explored the effect of tranexamic acid on pancreaticobiliary surgeries. hence we designed this study to compare the effect of two different doses of tranexamic acid in reducing intraoperative blood loss in pancreaticobiliary surgeries. 
Close