NCT03552705

Brief Summary

Patients who tear their ACL are at high risk for developing arthritis (post-traumatic osteoarthritis-PTOA) just 10 years later. Joint bleeding and inflammation contribute to deterioration of joint health. This study will determine whether treatment with Tranexamic Acid (TXA), an FDA approved medication that reduces bleeding right after ACL injury and reconstructive surgery reduces inflammation and improves joint health as a new strategy to prevent or delay the onset of PTOA.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
8mo left

Started Aug 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Aug 2019Jan 2027

First Submitted

Initial submission to the registry

May 29, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2027

Last Updated

February 27, 2026

Status Verified

January 1, 2026

Enrollment Period

7.5 years

First QC Date

May 29, 2018

Last Update Submit

February 25, 2026

Conditions

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (2)

  • Synovial fluid IL-1

    To determine whether TXA administered acutely after ACL injury reduces synovial fluid markers of inflammation and cartilage degradation

    Day 5

  • Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)

    To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves PRO (KOOS Quality of Life) at 6 months after ACLR. The Knee injury and Osteoarthritis Outcome Score (KOOS) assesses a patient's opinion about their knee and associated problems. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated.

    6 months post-ACLR

Secondary Outcomes (3)

  • Quantitative MRI (qMRI)

    6 months post-ACLR

  • Quantitative MRI

    2 years post-ACLR

  • Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)

    2 years post-ACLR

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

5-day course of standard adult oral tranexamic acid dosage of 1300 mg taken 3 times a day (3900 mg/day) and intravenous tranexamic acid during ACL reconstruction surgery (1 gram of iv TXA just prior to incision and 1 gram of iv TXA just prior to wound closure)

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

5-day course of placebo and intravenous saline during ACL reconstruction surgery

Drug: Placebos

Interventions

Tranexamic AcidDRUG

5-day course of oral standard adult oral tranexamic acid dosage of 1300 mg taken 3 times a day (3900 mg/day) and intravenous tranexamic acid during ACL reconstruction surgery (1 gram of iv TXA just prior to incision and 1 gram of iv TXA just prior to wound closure)

Tranexamic Acid
PlacebosDRUG

5-day course of oral placebo and intravenous saline during ACL reconstruction surgery

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-30 years
  • within 4 days of unilateral ACL injury
  • presence of effusion/hemarthrosis.

You may not qualify if:

  • inflammatory arthritis, radiographic osteoarthritis (K-L Grade 2 or higher), gout/ pseudogout
  • systemic or acute illness requiring medications
  • concomitant knee injury aside from meniscus tear and MCL tear not requiring surgery
  • prior surgery to either knee
  • prior injury to either knee requiring crutches
  • history of thromboembolic disease
  • current use of combination hormonal contraception
  • chronic NSAID use
  • cortisone injection to either knee within the prior 3 months
  • not indicated for or unable to undergo ACLR within 3 months of injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Constance Chu, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine L Hoang, BS

CONTACT

650-721-7612c1hoang@stanford.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blinded RCT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2018

First Posted

June 12, 2018

Study Start

August 1, 2019

Primary Completion (Estimated)

January 14, 2027

Study Completion (Estimated)

January 14, 2027

Last Updated

February 27, 2026

Record last verified: 2026-01

Locations

US(1)