Tranexamic Acid in Total Knee Replacement

Not Applicable

Completed

• Conditions: Osteo Arthritis Knee
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT03656445
• Lead Sponsor: Democritus University of Thrace

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.

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2018-08
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-08-31
• Last Update Submitted: 2018-08-31
• Study First Posted: 2018-09-04
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. varus deformity less than 10o
2. lack of extension not more than 10o
3. flexion of at least 90o.

Exclusion Criteria

1. uncontrolled medical diseases/comorbidities
2. allergy and/or hypersensitivity to TXA
3. a known history of thromboembolic disease, cardiovascular disease
4. coronary or vascular stent placed within the past 12 months
5. cerebral vascular disease (a history of stroke)
6. subarachnoid hemorrhage
7. preoperative coagulopathy (a platelet [PLT] count <150,000/mm3 or an international normalized ratio greater than 1.5
8. preoperative renal or hepatic dysfunction
9. retinal vein or artery occlusion
10. patients with anemia (<12 g/dL for female, <13 g/dL for male)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C - Tranexamic Acid	Tranexamic Acid	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
Group A - Tranexamic Acid	Tranexamic Acid	1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia
Group B - Tranexamic Acid	Tranexamic Acid	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
VAS pain (analogue pain scale)	2nd and 4th post op days + 6th week and 12th week	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 \[100-mm scale\])
Knee Society Score (KSS) KSS	2nd and 4th post op days + 6th week and 12th week	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)
Function Knee Society Score	2nd and 4th post op days + 6th week and 12th week	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)
EuroQol	2nd and 4th post op days + 6th week and 12th week	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)