Osteoarthritis
Conditions
Brief summary
TXA and EACA have been reported to reduce blood loss in cardiac and neuro surgery, but there is no literature available comparing the two in total knee arthroplasty (TKA). The investigators want to determine if TXA or EACA compared with placebo are effective and safe for blood loss prevention in TKA by comparing blood loss, transfusion rates, and total cost.
Interventions
DRUGTranexamic Acid
TXA as 10mg/kg x 1 dose in 100mL normal saline over 15 minutes prior to the procedure then an infusion of 1mg/kg/hr during the procedure + placebo (normal saline as the dummy for eACA.)
eACA as 150mg/kg in 250mL of IV normal saline over 15 minutes prior to the procedure then an infusion of 15mg/kg/hr during the procedure + placebo (normal saline as the dummy for TXA).
DRUGNormal Saline
Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.
Sponsors
Heekin Orthopedic Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients scheduled to receive primary unilateral total knee arthroplasty
Exclusion criteria
* Subject requires bilateral staged total knee arthroplasty * Religious beliefs that would limit blood transfusion * History of acquired defective color vision (inhibits monitoring for adverse events) * Patients with a known history of upper urinary tract bleeding * History of abnormal coagulation * Renal dysfunction defined by elevated BUN and CR or BUN to CR ratio of 20:1 within 30 days of surgery * Active intravascular clotting * Known allergy to either TXA or eACA * Myocardial Infarct within 6 months * History of stroke * Patient is a prisoner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood loss until the drain is removed | 24 hours |
Outcome results
None listed