Blood Loss, Knee Osteoarthritis, Pain, Postoperative
Conditions
Brief summary
A comparison of outcomes between use of oral tranexamic acid as compared to oral placebo in the first days after total knee replacement will be made to determine impact on clinical indications and patient reported outcomes.
Detailed description
Significant blood loss occurs during total knee arthroplasty (TKA) which can lead to adverse outcomes including need for blood transfusion as well as increased local tissue swelling and ecchymosis which can inhibit post-operative recovery. Tranexamic acid (TXA), an inhibitor of fibrinolysis, has been shown to be a safe and effective drug for reducing blood loss during and after TKA. The use of TXA intraoperatively has been associated with higher postoperative hemoglobin levels and a reduction in postoperative blood transfusion rates. Administration of TXA in TKA has also been associated with improved clinical outcome measures including decreased rate of periprosthetic joint infection, decreased length of stay, and increased postoperative range of motion and early ambulation distances. However, there remains a wide variance in the route of administration, dosage, and timing of TXA use among treatment protocols in TKA. Previous studies have evaluated outcomes with the addition of post-operative TXA dosing to standard pre-operative and intra-operative intravenous (IV) doses. This study will investigate patient outcomes following a standardized post-operative oral TXA protocol as compared to oral placebo for three doses over day of surgery, postop day one and postop day two after TKA. Following written consent documentation, Subjects will be randomized and blinded to randomization assignment until completion of study to either the oral TXA group or oral placebo group. The study medication will be distributed with the Subject's name with instructions for use in the post-anesthesia unit (PACU). The first dose will be administered in PACU with subsequent doses to be taken at home on postop day one and postop day two. TKA will be completed in an ambulatory surgery center with discharge same day of surgery to home. Outcome measures include: Hemoglobin, visual analog score, KOOS Jr (Knee injury and osteoarthritis outcome score), range of motion, and incidence of treatment-emergent adverse event at postoperative (POD) day 3, POD week 2, POD week 6, and POD week 12. KOOS Jr. will be collected at one year post-op.
Interventions
1950 mg tranexamic acid (three capsules) given in post-anesthesia room and three capsules for postop day one and three capsules for postop day two
DRUGPlacebo
Three capsules of cellulose given in post-anesthesia room and three capsules for postop cay one and three capsules for postop day two
Sponsors
Campbell Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Both oral TXA and oral placebo will be distributed to subjects in bottle marked with subject name and instructions for use following discharge from PACU.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Primary total knee replacement in ambulatory setting * Willing to participate * Physical therapy on site at Campbell Clinic Wolf River * Fluent in oral and written English
Exclusion criteria
* Unwilling to participate * Revision total knee replacement * Preoperative use of anticoagulants other than 81 mg aspirin * Previous history of thromboembolic event * Previous history of cancer other than non-melanoma skin cancers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin level | preoperative | Hemoglobin enables red cells to transport oxygen and carbon dioxide in the blood and is measured in grams per deciliter with normal ranges of 12.0 to 17.5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Score | preoperative | Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain |
| KOOS Jr Score | preoperative | Patient reported outcome of how the knee feels from 0 to one 100 where 0 represents extreme problems and 100 represents no problems |
| range of motion of knee | preoperative | clinical measurement of passive, pain-free range of motion of knee in degrees from 0 to 180 from maximum extension to maximum flexion |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse event | postoperative day 3 | monitoring for safety events |
Countries
United States
Outcome results
None listed