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CTRI Number  CTRI/2024/08/072959 [Registered on: 23/08/2024] Trial Registered Prospectively
Last Modified On: 22/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Tranexamic acid drug used to control blood loss in major surgery in orthopedics like total knee replacement. 
Scientific Title of Study   Effect of Tranexamic acid on peri operative blood loss in Primary Total Knee Replacement 
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 Sharad Sawant  
Designation  Junior Recident 
Affiliation  Datta Meghe Institute of Higher Education And Research Sawangi Meghe 
Address  Orthopedics Department, Jawaharlal Nehru medical college sawangi (meghe),Wardha, Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  7083881825  
Fax    
Email  sharadsawant506@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Deshpande 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education And Research Sawangi Meghe 
Address  Orthopedic department sawangi (meghe) Wardha Maharashtra , pin code -442001 Wardha Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  9860452519  
Fax    
Email  svd1111@gmail.com  
 
Details of Contact Person
Public Query  
Name  SHARAD SAWANT 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education And Research Sawangi Meghe 
Address  Orthopedics department, Jawaharlal Nehru medical college sawangi (meghe), Wardha, Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  07083881825  
Fax    
Email  sharadsawant506@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Wardha India-442001 
 
Primary Sponsor  
Name  JNMC 
Address  ORTHOPEDICS DEPARTMENT, JAWAHARLAL NEHRU MEDICAL COLLEGE, SAWANGI MEGHE, WARDHA, MAHARASHTRA, 442001. 
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 Sharad Sawant   Acharya Vinoba Bhave Rural Hospital   orthopedic department sawangi (meghe) Wardha Maharashtra , pin code -442004 Wardha Maharashtra
Wardha
MAHARASHTRA 		 7083881825

sharadsawant506@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: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous administration of Tranexamic acid   Intravenous administration of Tranexamic acid 30 minutes before the incision is used to control or prevent heavy or excessive bleeding after the major operative procedure in orthopaedic surgery, like total knee replacement.  
Comparator Agent  Peri articular infiltration of tranexamic acid at posterior aspect in whole capsule.  Peri articular infiltration of tranexamic acid at posterior aspect in whole capsule to control blood loss during major surgeries in orthopedics like total knee replacement. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient undergoing primary Total knee replacement due to osteoarthritis or rheumatoid arthritis. 
 
ExclusionCriteria 
Details  1)Allergies to drugs used
2)Changes related to coagulation profile
3)Use of Antiplatelet drugs seven days before surgery
4)Kidney or Liver disease
5)Previous history of deep venous thrombosis or pulmonary embolism 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
At the end of study their might be less blood loss in patient manage with intravenous tranexamic acid compare to patient manage with peri articular infiltration of tranexamic acid in posterior aspect of capsule.  Assessment will be done at 12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 2/ Phase 3 
Date of First Enrollment (India)   07/09/2024 
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="2"
Months="0"
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  

ABSTRACT

Tranexamic acid is an Anti-fibrinolytic agent. It is used to treat or prevent excessive blood loss from major trauma, major surgeries like Total knee replacement, Total hip replacement. Intravenous or topical administration of tranexamic acid seems to be an effective method in preventing blood loss and blood transfusions following TKR.as compared to infiltration of tranexamic acid in posterior aspect of whole capsule. Aim of this study to investigate the effect of tranexamic acid to control blood loss during surgery and post operative. In this study we propose to evaluate the use of tranexamic acid in reducing bleeding, need for transfusion of blood and blood products, and prevalence of deep vein thrombosis in primary TKR. Attention was paid to early complication potentially associated with TXA administration hematoma, wound exudate, or knee swelling.

 
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