Tranexamic Acid in Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
Multiple intravenous Tranexamic Acid doses can reduce postoperative blood loss and improve the functional outcome in total knee arthroplasty without tourniquet: a randomized controlled study.

Detailed Description
-----------------
A total of 180 patients undergoing TKA for knee osteoarthritis were stratified in three equal groups. All surgeries were performed under spinal anesthesia, without tourniquet and patients should be in agreement with the established inclusion/exclusion criteria. Group A (60 patients) received 1g of IV TXA, Group B (60 patients) received an additional dose of IV TXA and Group C (60 patients) received three doses of IV TXA. The measured outcomes were the Hemoglobin (Hb) decrease, the transfusion rate, the functional, quality of life (QoL) and pain assessment based on their corresponding scoring system.

Official Title
-----------------
Multiple Intravenous Tranexamic Acid Doses Can Reduce Postoperative Blood Loss and Improve the Functional Outcome in Total Knee Arthroplasty Without Tourniquet: a Randomized Controlled Study

Conditions
-----------------
Osteo Arthritis Knee

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid
* Drug: Tranexamic Acid
* Drug: Tranexamic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: varus deformity less than 10o lack of extension not more than 10o flexion of at least 90o. Exclusion Criteria: uncontrolled medical diseases/comorbidities allergy and/or hypersensitivity to TXA a known history of thromboembolic disease, cardiovascular disease coronary or vascular stent placed within the past 12 months cerebral vascular disease (a history of stroke) subarachnoid hemorrhage preoperative coagulopathy (a platelet [PLT] count <150,000/mm3 or an international normalized ratio greater than 1.5 preoperative renal or hepatic dysfunction retinal vein or artery occlusion patients with anemia (<12 g/dL for female, <13 g/dL for male)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A - Tranexamic Acid<br>1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia | Drug: Tranexamic Acid<br>* 1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia<br>* Other names: Cyklokapron;|
| Active Comparator: Group B - Tranexamic Acid<br>1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision and an additional dose of IV TXA (15mg/kg) in 100-ml normal saline 3 hours after skin incision | Drug: Tranexamic Acid<br>* 1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision and an additional dose of IV TXA (15mg/kg) in 100-ml normal saline 3 hours after skin incision<br>* Other names: Cyklokapron;|
| Active Comparator: Group C - Tranexamic Acid<br>1 dose of IV TXA (15mg/kg) in 100-ml normal saline, before incision and two additional doses of IV TXA (15mg/kg) in 100-ml normal saline 3 and 6 hours after skin incision respectively | Drug: Tranexamic Acid<br>* 1 dose of IV TXA (15mg/kg) in 100-ml normal saline, before incision and two additional doses of IV TXA (15mg/kg) in 100-ml normal saline 3 and 6 hours after skin incision respectivel<br>* Other names: Cyklokapron;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin change | Hemoglobin decrease/change during the four post-operative days | 1st,2nd and 4th post-operative day | 
| Blood loss | calculated total blood loss (TBL) the 1st post-op day | 24 hours | 
| Blood loss | calculated total blood loss (TBL) the 2nd post-op day | 48 hours | 
| Blood loss | calculated total blood loss (TBL) the 4th post-op day | 96 hours | 
| Platelet count change | Platelet count increase/decrease/change during the 1st,2nd and 4th day | 24 hours, 48 hours, 96 hours | 
| Need for trasfussion | Transfussion rate/quantity in 1st post-op day | 24 hours | 
| Need for trasfussion | Transfussion rate/quantity in 2nd post-op day | 48 hours | 
| Need for trasfussion | Transfussion rate/quantity in 3rd post-op day | 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score (KSS) KSS | Change in this Score which is an objective scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA. Maximum score is 100 (best functionality) and lowest score is 0 (worst functionality) | 2nd and 4th post op days + 6th week and 12th week | 
| Function Knee Society Score | Change in this score which utilizes walking distance and stair climbing as the main parameters, with deduction for the use of a walking aid. Maximum score is 100 (best functionality) and lowest score is 0 (worst functionality) | 2nd and 4th post op days + 6th week and 12th week | 
| EuroQol | Changes in this score which is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. Crosswalk value sets for the EQ-5D-5L has been used to asses the results into numbers. Maximum score is 1 (which means best quality of life) and the lowest is -0.594(which means the worst quality of life) | 2nd and 4th post op days + 6th week and 12th week | 
| VAS pain (analogue pain scale) | The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10 [100-mm scale]) | 2nd and 4th post op days + 6th week and 12th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total knee arthroplasty, tranexamic acid, without tourniquet, blood loss, function, multiple doses