| CTRI Number |
CTRI/2018/05/014106 [Registered on: 25/05/2018] Trial Registered Prospectively |
| Last Modified On: |
06/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Compare efficacy of TXA in two route of administration] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of use of both intravenous and intra articular injection of tranexamic acid with only intra-articular injection of tranexamic acid in reducing blood loss in total knee replacement patients in western india
|
|
Scientific Title of Study
|
To compare the efficacy of combined use of intravenous and Intra-articular injection of Tranexamic acid with intra-articular administration alone in reducing blood loss in Primary Total Knee Arthroplasty:
Randomized controlled trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yeshi Dorji |
| Designation |
PG STUDENT |
| Affiliation |
Armed Forces Medical College |
| Address |
Department Of Orthopedics
Golden Jubilee Block
Armed Forces Medical College
pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7264069572 |
| Fax |
|
| Email |
dorjiyeshi5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar Mishra |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department Of Orthopedics
Golden Jubilee Block
Armed Forces Medical College
pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7875443895 |
| Fax |
|
| Email |
anilortho2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yeshi Dorji |
| Designation |
PG STUDENT |
| Affiliation |
Armed Forces Medical College |
| Address |
Department Of Orthopedics
Golden Jubilee Block
Armed Forces Medical College
pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7264069572 |
| Fax |
|
| Email |
dorjiyeshi5@gmail.com |
|
|
Source of Monetary or Material Support
|
| LT(Dr) Yeshi Dorji
PG student
Dept of orthopedics
Golden Jubilee Block
Armed Forces Medical College
pune |
|
|
Primary Sponsor
|
| Name |
Yeshi Dorji |
| Address |
Dept of Orthopedics
Golden Jubilee Block
Armed Forces Medical College
pune |
| Type of Sponsor |
Other [] |
|
|
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 |
| Yeshi Dorji |
command hospital,pune |
Dept of orthopedics
Golden Jubilee Block
Armed Forces Medical college
pune
Pune
MAHARASHTRA |
00917264069572
dorjiyeshi5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical research cell & institutional ethical committee,Armed forces medical college,pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
All patients who are undergoing primary TKA, (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Tranexamic acid-intravenous and intra-articular combined vs intra-articular injection alone |
Intervention is to give both intravenous and intra-articular TXA to one group of patients who are undergoing primary TKA
Compare with only intra-articular injection alone group and find out the differences of amount of blood loss in primary TKA patient post operatively |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
In combined Group-1gm of TXA using I.V injection 15 mins before skin incision and 1gm of TXA using intra-articular intra operatively after closure of joint capsule in primary TKA
Single group-Receives only 1gm of TXA intra-articular intraoperatively after joint capsule closure in primary TKA.
|
|
| ExclusionCriteria |
| Details |
Patient unwilling for study-no consent
Patients allergic to TXA
Patient with known history of thromboembolic disease
Patients with cardiovascular disease like MI
Patients with history of cerebral vascular disease- stroke
pre op renal dysfunction
pre op coagulopathy plt less than 1.5lakh and INR more than 1.4 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare Fall in Haemoglobin level,haematocrit and Drain output |
post operative day Hb level on day 3, day 5 and day 14
Drain output is measured after 24 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the amount of blood loss with combined (intravenous and intra-articular) TXA in primary TKA
To evaluate amount of blood loss with only intra-articular administration of TXA in primary TKA |
Post operative day1,3,5 & 14 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/06/2018 |
| Date of Study Completion (India) |
28/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare the efficacy of combined group(I.V and intra-articular) vs single group(intra-articular only) in reducing post operative blood loss in primary TKA patients 1gm of TXA is given I.V 15 mins before skin incision and Intra-articular injection is given after closure of joint capsule Post operatively Heamoglobin and Haematocrit are evaluated on day 3, day5 and day 14 Drain output is measured after 24 hours post operative
Then blood loss of two groups are compared with data collected as mentioned above |