FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076136 [Registered on: 01/11/2024] Trial Registered Prospectively
Last Modified On: 01/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   it is trial in which a drug will be administered to the patient and its effect will be seen on reduction in post operative infection. 
Scientific Title of Study   A Randomized Control trial to evaluate the role/efficacy of single dose intravenous Tranexamic acid at the time of induction of anesthesia for post operative seroma formation in para-umbilical hernioplasty at a tertiary care center 
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. Rachit Jain 
Designation  Junior resident (General Surgery)  
Affiliation  KLE Academy of higher education and research 
Address  Room no. 107,NRI PG boys hostel JNMC Campus, Nehru nagar, belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9888521505  
Fax    
Email  rachit.jain774@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr BM Kajagar 
Designation  professor general surgery 
Affiliation  KLE Academy of higher education and research 
Address  JNMC Staff Quarters, department of General Surgery, Nehru Nagar, Belagavi-590010

Belgaum
KARNATAKA
590001
India 
Phone  8722630285  
Fax  0831-2493777  
Email  bmkajagar@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr BM Kajagar 
Designation  professor general surgery 
Affiliation  KLE Academy of higher education and research 
Address  JNMC Staff Quarters, department of General surgery, Nehru Nagar, Belagavi-590010

Belgaum
KARNATAKA
590001
India 
Phone  8722630285  
Fax  0831-2493777  
Email  bmkajagar@rediffmail.com  
 
Source of Monetary or Material Support  
KLES Dr. Prabhakar Kore hospital and medical research centre, belagavi 
 
Primary Sponsor  
Name  Dr Rachit Jain 
Address  Room no 107, NRI PG Boys hostel JNMC campus, KLE University , Belagavi, Karnataka 
Type of Sponsor  Private medical college 
 
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 Rachit Jain  KLES Dr Prabhakar Kore Hospital and Medical Research Centre   Department of General Surgery
Belgaum
KARNATAKA 		 9888521505
0831-2493777
rachit.jain774@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous Tranexamic acid  1 gram of Intravenous tranexamic acid given during the induction of anaesthesia 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  UNCOMPLICATED PARA-UMBILICAL HERNIAS AND AGES BETWEEN 18-70 YEARS 
 
ExclusionCriteria 
Details  Complicated/Strangulated Hernias, Hernias Associated with medical diseases affecting coagulation profile ,chronic renal insufficiency or failure , color or vision disorders, history of thrombo-embolic events, pregnant/lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post operative decrease in seroma formation by reducing drain output.  Post operative drain output will be measured on day 1, day 3 and day 5. 
 
Secondary Outcome  
Outcome  TimePoints 
IV tranexamic acid can cause adverse drug reaction   on the time of administration 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 3 
Date of First Enrollment (India)   01/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/12/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rachit.jain774@gmail.com].

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 30-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Tranexamic acid is a synthetic derivative of the amino acid lysine that exerts an anti-fibrinolytic action, used in the prevention and treatment of excessive bleeding both in primary and secondary care, first described in the 1960s; recent years have seen a resurgence of interest in its use in the management of bleeding and particularly in the context of severe trauma.Intravenous administration of tranexamic acid during major surgery has been shown to reduce postoperative bleeding by 34 percent. Intravenous dose of tranexamic acid (10mg /kg body weight) was usually given with induction of anaesthesia in para-umbilical hernioplasty. To the best of our knowledge, no up-to-date studies act on the effect of tranexamic acid on seroma formation and wound infection after paraumbilical hernioplasty. 
Close