| CTRI Number |
CTRI/2019/01/017105 [Registered on: 16/01/2019] Trial Registered Prospectively |
| Last Modified On: |
15/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the effect of the drug tranexamic acid on the blood loss and rate of blood transfusion by infiltrating it into the joint and by giving it directly into the vein in patients undergoing total knee replacement surgery. |
|
Scientific Title of Study
|
The effect of Intravenous and Intraarticular administration of Tranexamic acid on the Blood loss and Rate of blood transfusion after Total Knee replacement. A Randomized Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nissar Ahmad Shah |
| Designation |
Fellowship Arthroplasty |
| Affiliation |
Ganga Hospital |
| Address |
Department of Orthopaedics,Ganga Hospital.
313, Mettupalayam Rd, Saibaba Koil, Coimbatore, Tamil Nadu 641043
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9697839840 |
| Fax |
|
| Email |
shahnisar01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajkumar Natesan |
| Designation |
Senior Consultant |
| Affiliation |
Ganga Hospital |
| Address |
Department Of Orthopaedics,
Ganga Hospital
313, Mettupalayam Rd, Saibaba Koil, Coimbatore, Tamil Nadu 641043
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9443366258 |
| Fax |
|
| Email |
drrajkumarn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nissar Ahmad Shah |
| Designation |
Fellowship Arthroplasty |
| Affiliation |
Ganga Hospital |
| Address |
Department Of Orthopaedics,Ganga Hospital.
313, Mettupalayam Rd, Saibaba Koil, Coimbatore, Tamil Nadu 641043
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9697839840 |
| Fax |
|
| Email |
shahnisar01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Hospital
313, Mettupalayam Road,
Coimbatore. 641043
|
|
|
Primary Sponsor
|
| Name |
Ganga Hospital |
| Address |
313, Mettupalayam Rd, Saibaba Koil, Coimbatore, Tamil Nadu 641043 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nissar Ahmad Shah |
Ganga Hospital |
Department of Orthopaedics,Ganga Hospital.
313, Mettupalayam Rd, Saibaba Koil, Coimbatore, Tamil Nadu 641043
Coimbatore
TAMIL NADU |
9697839840
shahnisar01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Tranexamic Acid |
The Effect of the drug on blood loss during total knee replacement by intravenous administration
Dose: 15 mg/kg Body Weight
Route of Administration:Intravenous
Duration of Therapy:one dose |
| Intervention |
TRANEXAMIC ACID |
This drug is an anti fibrinolytic used for more than two decades to decrease the blood loss in surgeries.The aim of my study is to compare the effect of the drug on blood loss during total knee replacement.
Dose: 1.5 grams
Route of Administration: Intra Articular
Duration: One dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Primary unilateral osteoarthritis of knee joint |
|
| ExclusionCriteria |
| Details |
Diagnosis other than primary osteoarthritis
Previous knee surgery
Inflammatory and infectious arthritis
Underlying coagulopathy
Post traumatic arthritis
Patients receiving anticoagulation therapy
History of thromboembolic & cardiovascular disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The final outcome will be measured in terms of total blood loss and need for any blood transfusion |
2 Time Points .Immediate post operative and 4 weeks post opaerative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptomatic Deep Venous Thrombosis,Wound Complications And Infection |
2 Time points.Immediate post operative and 4 weeks post operative |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/02/2019 |
| 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="0"
Months="4"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The effect of intravenous and intraarticular administration of tranexamic acid on the blood loss and rate of blood transfusion after total knee replacement. A Randomized Controlled Study
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
TITLE: The Effect Of Intravenous And Intraarticular Administration Of Tranexamic Acid On The Blood Loss And Rate Of Blood Transfusion After Total Knee Replacement. A Randomized Controlled Study
AIMS AND OBJECTIVE To compare the amount of blood loss among the two groups receiving intraarticular and intravenous Tranexamic acid. To compare the allogenic blood transfusion rate among the two groups. To compare these regimens in terms of venous thromboembolism (VTE) and the frequency of wound complications |