Oral Tranexamic Acid After Total Knee Arthroplasty

Sponsor
Rush University Medical Center
Study ID
NCT06894719
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tranexamic acid Oral-Short Arm — DRUG
    1.95g Tranexamic acid daily for post op days 1 to 3
  • tranexamic acid Oral-Long Arm — DRUG
    1.95g tranexamic acid daily post op days 1-7
  • Control group placebo — DRUG
    Placebo for 3 days post-op

Study Details

This is a prospective, double-blind, randomized controlled trial evaluating the efficacy of oral tranexamic acid (TXA) in total knee arthroplasty (TKA). The study will assess pain, function, and range of motion (ROM) over a 2-year period, with key evaluations at 6 weeks and 90 days postoperatively. Hypothesis: Patients receiving 1.95g oral TXA for 3 or 7 days post-op will show improved pain, function, and ROM at 6 weeks and 90 days, with similar blood loss and transfusion rates as the control group.

Key Dates

First listed
Mar 25, 2025
Start date
Jun 1, 2026
Status verified
Feb 2026
Primary completion
Dec 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
351 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Oral-Short Arm: 1.95g TXA daily POD 1-3
    1.95g TXA daily for post operative days 1-3
  • Active Comparator: Oral-Long Arm
    1.95g TXA daily for post operative days 1-7
  • Placebo Comparator: Control Group: Placebo for 3 days post-op
    Placebo for 3 days post-op

Primary Outcome Measure

Primary endpoint: knee range of motion [ Time Frame: (flexion/extension) at 2 weeks and 6 weeks post op ]

Central Contacts

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