Osteoarthritis of Knee
Conditions
Brief summary
Total knee arthroplasty (TKA) may be associated with significant blood loss, and transfusion carries substantial risk of immunologic reaction and disease transmission. Several methods reportedly reduce postoperative blood loss and avoid homologous blood transfusion with traditional TKA approaches. Drain clamping was one of the widely used method and tranexamic acid administration was the recently adjuvant method to reduce blood loss in TKA. However, there were several regimens in either drain clamping or tranexamic acid administration reported in previous studies. Our objective was to compare the efficacy of our drain clamping protocol and/or tranexamic acid regimen for reducing blood loss and transfusion in TKA.
Interventions
OTHERNo clamp and placebo
The drain was not clamped. The patient received placebo (saline 10 minutes before surgery and three hours post-operative, and then an oral form of placebo 2X3 capsules for five days).
DRUGTranexamic acid
the drain was not clamped and the patient received tranexamic acid 10mg/kg intravenous 10 minutes before inflating the tourniquet and 10mg/kg intravenous three hours post-operative, and then tranexamic acid 250mg/capsule 2X3 orally for five days.
PROCEDUREDrain clamping
the drain was clamped for three hours, released for three hours, then clamped for another three hours, and then released free for 48 hours. The patient received placebo (saline 10 minutes before surgery and three hours post-operative, and then an oral form of placebo 2X3 capsules for five days).
OTHERDrain clamping and tranexamic acid
the drain was clamped for three hours, released for three hours, then clamped for another three hours, and then released free for 48 hours. the patient received tranexamic acid 10mg/kg intravenous 10 minutes before inflating the tourniquet and 10mg/kg intravenous three hours post-operative, and then tranexamic acid 250mg/capsule 2X3 orally for five days.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* The patients younger than 85 years with knee osteoarthritis
Exclusion criteria
* The patient diagnosed secondary osteoarthritis (eg, rheumatoid arthritis, posttraumatic arthritis, gouty arthritis, postseptic arthritis) * High-risk medical comorbid patient * The patient who was planed for simultaneous bilateral TKAs * The patient who had history of thromboembolic disease or bleeding disorder * The patient who was receiving anticoagulant drug treatment * The patient who had allergy to tranexamic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative blood loss | 48 hours after operation |
Secondary
| Measure | Time frame |
|---|---|
| Number of blood transfusion | 5 days |
Outcome results
None listed