| CTRI Number |
CTRI/2017/04/008401 [Registered on: 24/04/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of local versus systemic tranexamic acid in total knee replacement |
|
Scientific Title of Study
|
INTRAVENOUS VERSUS INTRA-ARTICULAR ADMINISTRATION OF TRANEXAMIC ACID FOR CONTROL OF PERI-OPERATIVE BLOOD LOSS IN TOTAL KNEE REPLACEMENT SURGERIES - A RANDOMISED CONTROLLED EQUIVALANCE TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Koushik Narayan Subramanyam |
| Designation |
Consultant |
| Affiliation |
Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram |
| Address |
Room No.142
Dept of Orthopedics
Puttaparthi
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
9491629620 |
| Fax |
|
| Email |
drkoushik@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Koushik Narayan Subramanyam |
| Designation |
Consultant |
| Affiliation |
Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram |
| Address |
Room No.142
Dept of Orthopedics
Puttaparthi
ANDHRA PRADESH
515134
India |
| Phone |
9491629620 |
| Fax |
|
| Email |
drkoushik@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tulaja Prasad P V |
| Designation |
Junior Resident |
| Affiliation |
Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram |
| Address |
Room No.142
Dept of Orthopedics
Puttaparthi
Room No.142
Dept of Orthopedics
Puttaparthi
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
9008475444 |
| Fax |
|
| Email |
doctortulajaprasad@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Sathya Sai Institute of Higher Medical Sciences Prasanthigram |
| Address |
ROOM NO. 142
DEPT OF ORTHOPAEDICS
PUTTAPARTHI, ANDHRA PRADESH. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Koushik Narayan Subramanyam |
Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram |
Room No 142
Dept of Orthopaedics
Puttaparthi
Anantapur
ANDHRA PRADESH |
9491629620
9491629620
drkoushik@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics and Scientific Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Primary osteoarthritis knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraarticualr administration of tranexamic acid |
1.5g of TXA in 10 ml of normal saline injected into the joint through 18 gauge needle after wound closure before tourniquet release |
| Comparator Agent |
Intravenous administration of tranexamic acid |
Intravenous Tranexamic acid at 10 mg /kg over 10 minutes before tourniquet inflation and again 10mg/kg 10 min before tourniquet release |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients undergoing total knee arthroplasty for primary arthroplasty knee
2.Patients who are willing to participate in the study.
3.Patient without exclusion criteria.
|
|
| ExclusionCriteria |
| Details |
1.Allergy to the TXA
2.H/O Coagulopathy,abnormal PT or APTT
3.Past H/O Thromboembolic event
4.Treatment with Aspirin or NSAIDS in the last week
5.plasma creatinine > 115 micro moles /litre for males
And >100 micro moles/litre in females.
6.Acute infection[eg;leukocytosis or fever]
7.Malignancy
8.MI in preceding 12 months,unstable angina
9.Patient who were given plasma in perioperative period.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative Hemoglobon drop |
Assessed at 5 days of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perioperative blood loss, need for post operative blood transfusion, impairment of renal function, occurrence of deep vein thrombosis |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
01/05/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is intended to test for equivalence between intraarticular and intravenous routes for administration of tranexamic acid for control of perioperative blood loss in total knee replacement in terms of efficacy and safety. |