| CTRI Number |
CTRI/2018/05/013588 [Registered on: 01/05/2018] Trial Registered Prospectively |
| Last Modified On: |
14/09/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A trial to compare efficiency of a drug used to reduce blood loss in surgical procedures when given through veins at different timings before, during and after surgery. |
|
Scientific Title of Study
|
A comparitive study of efficacy of preoperative administration of single high dose intravenous tranexamic acid versus multiple boluses of intravenous tranexamic acid in primary total knee arthroplasty
|
| Trial Acronym |
TAKR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KRISHNA TEJA KANDRA |
| Designation |
FELLOW IN ARTHROPLASTY |
| Affiliation |
SUNSHINE HOSPITALS |
| Address |
Sunshine hospitals, Penderghast Road, Opposite Parsi Dharamsala, Paradise, Secunderabad.
Hyderabad
ANDHRA PRADESH
500003
India |
| Phone |
9900280177 |
| Fax |
|
| Email |
kt18588@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KRISHNA TEJA KANDRA |
| Designation |
FELLOW IN ARTHROPLASTY |
| Affiliation |
SUNSHINE HOSPITALS |
| Address |
Sunshine hospitals, Penderghast Road, Opposite Parsi Dharamsala, Paradise, Secunderabad.
Hyderabad
ANDHRA PRADESH
500003
India |
| Phone |
9900280177 |
| Fax |
|
| Email |
kt18588@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KRISHNA TEJA KANDRA |
| Designation |
FELLOW IN ARTHROPLASTY |
| Affiliation |
SUNSHINE HOSPITALS |
| Address |
Sunshine hospitals, Penderghast Road, Opposite Parsi Dharamsala, Paradise, Secunderabad.
Hyderabad
ANDHRA PRADESH
500003
India |
| Phone |
9900280177 |
| Fax |
|
| Email |
kt18588@gmail.com |
|
|
Source of Monetary or Material Support
|
| SUNSHINE HOSPITALS, Sunshine hospitals, Penderghast Road, Opposite Parsi Dharamsala, Paradise, Secunderabad |
|
|
Primary Sponsor
|
| Name |
SUNSHINE HOSPITALS |
| Address |
Penderghast Road, Opposite Parsi Dharamsala, Paradise, Secunderabad, Telangana 500003 |
| 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 |
| KRISHNA TEJA KANDRA |
SUNSHINE HOSPITALS |
Room no.1, Department of orthopedics, Penderghast Road, Opposite Parsi Dharamsala, Paradise, Secunderabad, Telangana 500003
Hyderabad
ANDHRA PRADESH |
9900280177
kt18588@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SUNSHINE HOSPITALS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Total blood loss in total knee replacement., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tranexamic acid will be administered in the study to evaluate its effect on decreasing total blood loss in total knee replacement when given through intravenous route as a single large dose / multiple divided doses at different timings of the procedure. |
GROUP A- Receive single bolus of 20mg/kg IV-TXA 20mins. before
inflation of the torniquet .
GROUP B- Receive two boluses of 10mg/kg IV-TXA 20mins before inflation
of torniqet and before deflation of the tourniquet.
GROUP C- Receive two boluses of 10mg/kg IV-TXA before deflation and
three hours after 1 st dose.
GROUP D- Receive two boluses of 10mg/kg IV-TXA before inflation and
three hours after deflation.
GROUP E- Receive placebo(no treatment/ control group). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Informed consent
Those undergoing primary unilateral knee replacement. |
|
| ExclusionCriteria |
| Details |
Abnormal PT/APTT/INR or coagulopathic diseases
Undergoing B/L TKR / revision surgeries of any cause
Past h/o thromboembolic events
Treated with Aspirin or any anti-platelets within 1 week prior to the surgery
TKR done for secondary OA (rheumatoid arthritis, post traumatic arthritis)
History of reported allergy to tranexamic acid
Pre operative hemoglobin <8gm/dl
Chronic renal insufficiency |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Total blood loss
-Change in hematocrit levels on post-operative day 2 |
-Total blood loss
-Change in hematocrit levels on post-operative day 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Transfusion rates
2.Deep vein thrombosis
3.Pulmonary embolisation rates
-Operative time |
1.5th post operative day
2.90 days
3.90 days |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2018 |
| Date of Study Completion (India) |
31/08/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/08/2018 |
|
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 yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomised parallel group placebo controlled, single centre study to compare the efficacy of intravenous tranexamic acid administration of a single large dose or multiple timed doses in total knee replacement. This study is conducted in sunshine hospitals, Secunderabad, Telangana. The primary outcomes are blood loss, change in hematocrit levels on 2nd postoperative day. The secondary outcomes are transfusion rates, deep venous thrombosis, pulmonary embolisation rates.
References: 1. Seol YJ, Seon JK, Lee SH, et al. Effect of tranexamic acid on blood loss and blood transfusion reduction after total knee arthroplasty. Knee Surg Relat Res. 2016;28:188–93. doi:10.5792/ksrr.2016.28.3.188
2. Maniar RN, Kumar G, Singhi T, et al. Most effective regimen of tranexamic acid in knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin Orthop Relat Res 2012;470: 2605–12.
3. Benoni G, Lethagen S, Fredin H. The effect of tranexamic acid on local and plasma fibrinolysis during total knee arthroplasty. Thromb Res1997;85:195–206
4. Banerjee S, Kapadia BH, Issa K, et al. Postoperative blood loss prevention in total knee arthroplasty. J Knee Surg 2013;26:395–400
5. Seo JG, Moon YW, Park SH, et al. The comparative efficacies of intraarticular and IV tranexamic acid for reducing blood loss during total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 2013;21: Soni A, Saini R, Gulati A, et al. Comparison between intravenous and intra-articular regimens of tranexamic acid in reducing blood loss during Total knee arthroplasty. J Arthroplasty 2014;29:1525–7 |