Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Matthew Grosso, MD
Study ID
NCT06479161
Phase
PHASE2
Status
Recruiting
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Conditions

  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Tranexamic acid — DRUG
    1.95 grams oral

Study Details

The primary purpose of this study is to evaluate postoperative pain. Secondary outcomes evaluated in this study will include range of motion (ROM), opioid consumption, and ambulation. Each outcome measure will be evaluated, oral tranexamic acid (TXA) in the experiment arm and placebo in the control arm, after total knee arthroplasty (TKA) at postoperative days 0-3, and weeks 1, 2, 6, and 12.

Key Dates

Start date
Jun 10, 2024
Status verified
Dec 2024
Primary completion
Feb 28, 2025
Completion
Mar 30, 2025

Study Design

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

Arms

  • Active Comparator: TXA
    \- 1.95 grams oral TXA (tranexamic acid) (3- 650 mg tablets) administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use.
  • Placebo Comparator: Placebo
    \- 3 tablets administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use.

Primary Outcome Measure

Visual Analogue Scale (VAS) Pain scores [ Time Frame: postoperative day (POD) 0, 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Trinity Health Of New England/CT Joint Replacement InstituteHartfordConnecticut06105
Gina Panek, BS
[email protected]
860-714-4164
Czarina Weinz
[email protected]
860-714-0467
Matthew Grosso, MD (PRINCIPAL_INVESTIGATOR)

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