Extended Postoperative Oral Tranexamic Acid in Knee Replacement

Phase 4

Active, not recruiting

• Conditions: Knee Osteoarthritis; Blood Loss; Pain, Postoperative
• Interventions: Drug: Tranexamic Acid Pill; Drug: Placebo

• Registration Number: NCT05099276
• Lead Sponsor: Campbell Clinic

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.

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-10-29
• Study Start: 2021-12-07
• Primary Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral TXA	Tranexamic Acid Pill	1,950 mg oral tranexmic acid (three capsules of 650 mg) administered in post-anesthesia care, postop day one and postop day two. Compounded by registered pharmacist and labeled with subject name and instructions for use.
Oral placebo	Placebo	Three capsules of cellulose administered in post-anesthesia care, postop day one and postop day two. Compounded by registered pharmacist and labeled with subject name and instructions for use.

Primary Outcome Measures

Name	Time	Method
Hemoglobin level	postoperative week 2	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 Outcome Measures

Name	Time	Method
Visual Analog Score	postoperative week 12	Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain
KOOS Jr Score	postoperative one year	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	postoperative week 12	clinical measurement of passive, pain-free range of motion of knee in degrees from 0 to 180 from maximum extension to maximum flexion

Trial Locations

Locations (1)

Campbell Clinic; 🇺🇸 Germantown, Tennessee, United States