Clinical trial NCT05099276: Extended Postoperative Oral Tranexamic Acid in Knee Replacement
Official title: Extended Postoperative Tranexamic Acid Use in Primary Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Knee Osteoarthritis
Blood Loss
Pain, Postoperative
Lead sponsor: Campbell Clinic
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin level
timeFrame: preoperative
measure: Hemoglobin level
timeFrame: postoperative hour 3
measure: Hemoglobin level
timeFrame: postoperative day 3
measure: Hemoglobin level
timeFrame: postoperative week 2
Secondary outcomes:
measure: Visual Analog Score
timeFrame: preoperative
measure: Visual Analog Score
timeFrame: postoperative hour 3
measure: Visual Analog Score
timeFrame: postoperative week 2
measure: Visual Analog Score
timeFrame: postoperative week 6
measure: Visual Analog Score
timeFrame: postoperative week 12
measure: KOOS Jr Score
timeFrame: preoperative
measure: KOOS Jr Score
timeFrame: postoperative day 3
measure: KOOS Jr Score
timeFrame: postoperative week 2
measure: KOOS Jr Score
timeFrame: postoperative week 6
measure: KOOS Jr Score
timeFrame: postoperative week 12
measure: KOOS Jr Score
timeFrame: postoperative one year
measure: range of motion of knee
timeFrame: preoperative
measure: range of motion of knee
timeFrame: postoperative day 3
measure: range of motion of knee
timeFrame: postoperative week 2
measure: range of motion of knee
timeFrame: postoperative week 6
measure: range of motion of knee
timeFrame: postoperative week 12
Other outcomes:
measure: Incidence of treatment-emergent adverse event
timeFrame: postoperative day 3
measure: Incidence of treatment-emergent adverse event
timeFrame: postoperative week 2
measure: Incidence of treatment-emergent adverse event
timeFrame: postoperative week 6
measure: Incidence of treatment-emergent adverse event
timeFrame: postoperative week 12
Locations:
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
Study officials:
affiliation: Campbell Clinic
name: Marcus C Ford, MD
role: PRINCIPAL_INVESTIGATOR
References:
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