| CTRI Number |
CTRI/2017/07/009076 [Registered on: 18/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
17/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| 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
|
The comparative Efficacy and Safety of Topical and Intravenous Tranexamic acid for Reducing Perioperative Blood Loss in Total Knee Arthroplasty- A Randomized Controlled Non-inferiority 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 Jefferson George |
| Designation |
Fellow in Arthroplasty |
| Affiliation |
Sunshine Hospitals, Secunderabad |
| Address |
Sunshine Hospitals, Department of Orthopaedics, Room No.1, PG Road, Paradise, 03 TS, India
Hyderabad
ANDHRA PRADESH
500003
India |
| Phone |
|
| Fax |
|
| Email |
jeffgeorge007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jefferson George |
| Designation |
Fellow in Arthroplasty |
| Affiliation |
Sunshine Hospitals, Secunderabad |
| Address |
Sunshine Hospitals, Department of Orthopaedics, Room No.1, PG Road, Paradise, 03 TS, India
Hyderabad
ANDHRA PRADESH
500003
India |
| Phone |
|
| Fax |
|
| Email |
jeffgeorge007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jefferson George |
| Designation |
Fellow in Arthroplasty |
| Affiliation |
Sunshine Hospitals, Secunderabad |
| Address |
Sunshine Hospitals, Department of Orthopaedics, Room No.1, PG Road, Paradise, 03 TS, India
Hyderabad
ANDHRA PRADESH
500003
India |
| Phone |
|
| Fax |
|
| Email |
jeffgeorge007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SUNSHINE HOSPITALS |
| Address |
PG ROAD, PARADISE, SECUNDERABAD, 03 TS, INDIA |
| 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 |
| JEFFERSON GEORGE |
SUNSHINE HOSPITALS |
Department of Orthopaedics, Room No.1,
PG ROAD, PARADISE, SECUNDERABAD, 03 TS, INDIA
Hyderabad
ANDHRA PRADESH |
09447777890
jeffgeorge007@gmail.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 |
Intraarticular 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 |
40.00 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 Hemoglobin drop |
Assessed at 3 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="113"
Sample Size from India="113"
Final Enrollment numbers achieved (Total)= "113"
Final Enrollment numbers achieved (India)="113" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/01/2017 |
| Date of Study Completion (India) |
28/04/2017 |
| 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)
|
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 non-inferiority between intraarticular and intravenous routes for administration of tranexamic acid for control of perioperative blood loss in total knee replacement surgeries in terms of efficacy and safety |