Blood Loss, Surgical
Conditions
Keywords
Blood loss, Tranexamic acid, Total knee arthroplasty, Topical administration
Brief summary
The purpose of this study is to compare blood loss between using low dose (500 mg) and high dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in double-blind RCT
Interventions
DRUGTranexamic Acid
IA (intra-articular) tranexamic acid after capsule closure
Sponsors
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Osteoarthritic knee who underwent primary total knee arthroplasty
Exclusion criteria
* Abnormal coagulation or bleeding disorder * Allergy to tranexamic acid * History of thromboembolism or ischemic heart disease or cerebrovascular accident * chronic kidney disease stage 3-4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total blood loss | 72 hours after TKA | Blood loos that calculated from Haemoglobin drop at 72 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood transfusion | 0-72 hours after surgery | incidence of blood transfusion after surgery |
| Rate of participants with thromboembolism | At 72 hours and 2 weeks after surgery | Clinical thromboembolism after surgery |
| Rate of participants with infection | 0-3 months after surgery | Superficial or deep infection after TKA |
| Knee ROM | At 2, 6 weeks after surgery | Range of motion of the knee |
| Functional score | At 6 weeks after surgery | Modified WOMAC |
Countries
Thailand
Outcome results
None listed