Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction: A Multicenter Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Campbell Clinic
- Enrollment
- 100
- Locations
- 12
- Primary Endpoint
- Visual Analog Scale
Study Overview
Brief Summary
This is a prospective, multi-center, randomized, double-blind, placebo-controlled trial evaluating the efficacy of oral tranexamic acid (TXA) in improving postoperative outcomes following anterior cruciate ligament reconstruction (ACLR) using patellar tendon autograft in adolescent and young adult patients.
A total of 100 patients, aged 14 to 22 years and undergoing eligible ACLR, will be enrolled across multiple participating sites. Eligible participants will be randomized 1:1 to receive either oral TXA (1.95 g per day, divided into three 650 mg capsules) or placebo (microcrystalline cellulose) once daily from postoperative day 1 to 10, in addition to standard intraoperative care. All participants will receive 1 g IV TXA prior to incision and 1 g IV TXA at closure, per standard surgical protocol.
The primary outcome is improvement in postoperative pain, as measured by the Visual Analog Scale (VAS). Secondary outcomes are knee range of motion, quadriceps strength, isokinetic strength, time to straight leg raise, time to return to sport, International Knee Documentation Committee score, Lyshom score, and morphine milligram equivalents. Participants will be followed through routine postoperative visits at the participating institutions out to one year with a phone call for patient reported outcomes at 2 years.
Detailed Description
This multi-center, prospective, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the effect of oral tranexamic acid (TXA) on postoperative outcomes following anterior cruciate ligament reconstruction (ACLR) using bone-tendon-bone (BTB) autograft in adolescent and young adult patients.
Background:
Tranexamic acid is a synthetic antifibrinolytic agent that competitively inhibits plasminogen activation, helping to reduce bleeding. IV TXA is routinely used during orthopedic procedures, including ACLR, and has been shown to reduce intraoperative blood loss. However, the benefit of extending antifibrinolytic coverage with oral TXA in the early postoperative period has not been well studied in this population. This trial aims to investigate whether a 10-day postoperative course of oral TXA improves pain and recovery outcomes following ACLR.
Study Design:
Participants will be randomized in a 1:1 ratio to receive either oral TXA or a placebo. Randomization will be conducted using computer-generated allocation. Both the participants and the study team will remain blinded to group assignment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to 22 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •14-22 year old individuals with ACL tear undergoing primary ACLR with patellar tendon autograft.
- •Closed or closing proximal tibial and distal femoral physes on pre-operative radiographs (less than one year of growth remaining based on MRI and radiographic bone age assessment)
- •Fluent in English
- •Willing to participate
- •Patient weight greater than or equal to 100lbs (45.4kg)
Exclusion Criteria
- •Revision ACLR, multi-ligamentous knee reconstruction, inclusion of lateral extra-articular tenodesis (LET) or Anterolateral Ligament (ALL) reconstruction
- •Concomitant meniscal repair or chondral preservation surgery requiring postoperative limited weightbearing status (nonweightbearing or partial weightbearing)
- •Have a prior history of deep vein thrombosis (DVT) or thromboembolic event
- •Known allergy or hypersensitivity to TXA
- •Using combination hormonal contraception
Arms & Interventions
Oral TXA
Participants in this arm will receive oral tranexamic acid (TXA), 1.95 g daily (three 650 mg capsules) from POD 1 to POD 10, for a total of 10 doses (30 capsules). All participants will also receive 1 g IV TXA before incision and 1 g IV TXA at surgical closure as part of standard care.
Intervention: Tranexamic Acid (TXA) (Drug)
Placebo
Participants in this arm will receive oral placebo capsules (microcrystalline cellulose), 3 capsules daily from postoperative day (POD) 1 to POD 10, for a total of 10 doses (30 capsules). All participants will also receive 1 g IV TXA before incision and 1 g IV TXA at surgical closure as part of standard care.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Visual Analog Scale
Time Frame: Pre-op and 2 week, 6 week, 12 week, 6 months, 1 year, 2 year post op
The Visual Analog Scale (VAS) is a validated patient-reported outcome measure used to assess pain intensity. Patients rate their pain on a scale from 0 (no pain) to 10 (worst imaginable pain).
Secondary Outcomes
- Knee Range of Motion(Pre-op and 2-week, 6-week, 12-week, 6 months, 1-year post-op)
- Quadriceps Strength(Pre-op and 2-week, 6-week, 12-week, 6 months, 1-year post-op)
- Isokinetic Strength(6 months, 9 months, 1-year post-op)
- Time to Straight Leg Raise(Up to 1 year)
- Time to Return to Sport(Up to 1 year)
- International Knee Documentation Committee Score(Pre-op and 6 months, 1-year, 2-years post-op)
- Lysholm Knee Score(Pre-op and 6 months, 1-year, 2-years post-op)
- Morphine Milligram Equivilants(2 weeks following surgery)
Investigators
Frederick Azar
Chief of Staff
Campbell Clinic