Health TrialsbyHealthPanel

Oral Tranexamic Acid After Total Knee Arthroplasty

ConditionTotal Knee Arthroplasty
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any patient undergoing primary TKA at Rush main hospital or participating ASC

Willingness to undergo randomization to take medication potentially up to 7 days post op.

Willing to answer daily questions on pain, functionality and opioid consumption

Disqualifiers

History of venous thromboembolism, MI, or stroke in the past year

Patients on any chronic anticoagulation medications besides Aspirin

Patients with Cancer

Patients with end stage renal disease that are on dialysis

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

351 Participants
are divided into 3 treatment groups
Group A: Oral-Short Arm: 1.95g TXA daily POD 1-3Active comparator 1 intervention
Group B: Oral-Long ArmActive comparator 1 intervention
Group C: Control Group: Placebo for 3 days post-opPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary endpoint: knee range of motion

Primary Endpoint: Knee ROM

Time frame
(flexion/extension) at 2 weeks and 6 weeks post op

Secondary outcomes

1

Secondary" VAS pain scores

Pain scores (VAS)

Time frame
2 weeks, 6 weeks, and 3 months post op
2

Secondary: KOOS Jr

Time frame
2 weeks. 6 weeks, 3 months post op
3

secondary: EQ-5D-3L functional scores

Time frame
2 weeks, 6 weeks, and 3 months post op
4

Adverse events and complications

Any adverse events or complications after surgery

Time frame
3 months post op

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rush University Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: