ACL InjuryPhase 4NCT07115056
Extended Oral Tranexamic Acid After Anterior Cruciate Ligament Reconstruction
A Phase 4 study testing Tranexamic Acid (TXA) in people with ACL Injury and ACL Tears, run by Campbell Clinic at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 22 years
- Conditions the study is for
- ACL Injury, ACL Tears, ACL Surgery
- What is being tested?
- Tranexamic Acid (TXA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Apr 2026to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Washington University School of Medicine in St. Louis
Chesterfield, Missouri, 63017
University of Cincinnati
Cincinnati, Ohio, 45221
Duke University School of Medicine
Durham, North Carolina, 27705
Endeavor Health
Evanston, Illinois, 60201
Campbell Clinic
Germantown, Tennessee, 38138
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction: A Multicenter Randomized Controlled Trial
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.
Read the 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.
Group A (Placebo): Participants will receive 10 doses (30 capsules total) of microcrystalline cellulose (placebo), to be taken daily from postoperative day (POD) 1 through POD 10.
Group B (Oral TXA): Participants will receive 10 doses (30 capsules total) of oral TXA, dosed at 1.95 g per day (650 mg per capsule, 3 capsules daily) from POD 1 through POD 10.
All participants will receive standard intraoperative care, including 1 gram IV TXA prior to skin incision and an additional 1 gram IV TXA at surgical closure. Postoperative pain management will be administered per standard clinical practice and at the discretion of the treating surgical team.
Patient Population:
The study will enroll 100 patients aged 14 to 22 years undergoing isolated ACLR with a BTB autograft at Campbell Clinic Surgery Center and collaborating study sites.
Study Procedures:
Eligible patients will be identified via chart review and approached in clinic or via phone. Informed consent (and assent where applicable) will be obtained during a routine preoperative visit. Baseline data will be collected, including demographics and medical history. Participants will then be randomized and provided with study medication (oral TXA or placebo) to begin on POD 1.
Outcomes: 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.
Blinding and Allocation:
All capsules will be identical in appearance and packaging to maintain blinding. Randomization will be performed centrally and allocation concealed. Study staff, treating physicians, and patients will remain blinded until data analysis.
Safety Monitoring:
Participants will be monitored for adverse events throughout the study period. TXA is generally well tolerated but may pose thrombotic risk in susceptible individuals; exclusion criteria are designed to minimize this risk. The study team will report any serious adverse events (SAEs) to the IRB per institutional guidelines.
The study is powered to detect clinically meaningful differences in VAS scores, with a planned enrollment of 50 patients per group, allowing for a 20% loss to follow-up. This trial aims to clarify the role of extended postoperative oral TXA in reducing inflammation, pain, and bleeding in young ACLR patients, potentially offering a low-cost adjunct to current perioperative care.
- Conditions
- ACL Injury, ACL Tears, ACL Surgery
- Being tested
- Tranexamic Acid (TXA), Placebo
- Keywords
- ACL, ACL Repair, ACL Reconstruction, TXA, tranexamic acid
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (TXA)Drug
Oral tranexamic acid (TXA) is administered at a dose of 1.95 grams per day, divided into three 650 mg capsules taken once daily, starting on postoperative day (POD) 1 through POD 10 (10 total doses; 30 capsules) to the treatment group.
PlaceboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Oral TXA | Experimental | 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. Receives: Drug: Tranexamic Acid (TXA) |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
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).
Measured: Pre-op and 2 week, 6 week, 12 week, 6 months, 1 year, 2 year post op
Secondary outcomes (8)
Knee Range of Motion
Knee range of motion (ROM) will be assessed during visits using a goniometer to measure flexion and extension.
Measured: Pre-op and 2-week, 6-week, 12-week, 6 months, 1-year post-op
Quadriceps Strength
Quadriceps strength will be assessed using a dynamometer.
Measured: Pre-op and 2-week, 6-week, 12-week, 6 months, 1-year post-op
Isokinetic Strength
Isokinetic strength will be tested through biodex testing.
Measured: 6 months, 9 months, 1-year post-op
Time to Straight Leg Raise
Time to Straight Leg Raise (SLR) is defined as the number of days from surgery to the first postoperative day on which the patient can perform an active straight leg raise without an extensor lag.
Measured: Up to 1 year
Time to Return to Sport
Time to Return to Sport is defined as the number of days from surgery to the patient's clearance to resume full participation in sport-specific activities. Clearance is determined by the treating provider based on clinical evaluation, functional testing, and rehabilitation progress. This measure reflects overall recovery and readiness to return to pre-injury activity levels.
Measured: Up to 1 year
International Knee Documentation Committee Score
The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form is a validated, patient-reported outcome measure used to assess symptoms, function, and sports activity in individuals with knee disorders. Scores range from 0 to 100, with higher scores indicating better function and fewer symptoms.
Measured: Pre-op and 6 months, 1-year, 2-years post-op
Lysholm Knee Score
The Lysholm Knee Scoring Scale is a validated, patient-reported outcome measure used to assess knee function, symptoms, and stability following ligament injuries. Scores range from 0 to 100, with higher scores indicating better knee function.
Measured: Pre-op and 6 months, 1-year, 2-years post-op
Morphine Milligram Equivilants
Morphine Milligram Equivalents (MMEs) will be used to quantify opioid consumption in the postoperative period (2 weeks post-op). All prescribed and consumed opioid medications will be converted to MMEs using standard CDC conversion factors. Total MMEs will be calculated for each participant over the initial postoperative period.
Measured: 2 weeks following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Why it stopped: Difficulty with study implement study related to staffing issue \& approvals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campbell Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, University of Pittsburgh, Endeavor Health, University of Cincinnati, Washington University School of Medicine
- Responsible party
- Principal investigator, Frederick Azar, Campbell Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115056
- Sponsor's protocol ID
- Oral TXA After ACL-R
- Status last verified
- Feb 2026
- First submitted
- 30 Jul 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to concerns about participant privacy and confidentiality, limitations in resources to properly de-identify and manage data sharing, and institutional policies restricting data access. These measures are in place to ensure compliance with ethical standards and protect sensitive participant information.
Publications
Vermeijden HD, Yang XA, Rademakers MV, Kerkhoffs GMMJ, van der List JP, DiFelice GS. Early and Delayed Surgery for Isolated ACL and Multiligamentous Knee Injuries Have Equivalent Results: A Systematic Review and Meta-analysis. Am J Sports Med. 2023 Mar;51(4):1106-1116. doi: 10.1177/03635465211069356. Epub 2022 Jan 31.
PubMed 35099334Tan TK, Ng KT, Lim HJ, Radic R. Effect of tranexamic acid in arthroscopic anterior cruciate ligament repair: A systematic review and meta-analysis of randomised clinical trials. J Orthop Surg (Hong Kong). 2021 May-Aug;29(2):23094990211017352. doi: 10.1177/23094990211017352.
PubMed 34027721Romereim SM, Smykowski MR, Ball EK, Carey EG, Cuadra M, Williams A, Hickson K, Haim K, Sumith M, Yu Z, Jin G, Foureau D, Steuerwald N, Odum S, Fearing BV, Riboh JC. Immunophenotyping of Synovial Tissue in Adolescents Undergoing ACL Reconstruction: What Is the Role of Synovial Inflammation in Arthrofibrosis? Am J Sports Med. 2025 Feb;53(2):315-326. doi: 10.1177/03635465241305411. Epub 2025 Jan 7.
PubMed 39772756Kirwan MJ, Diltz ZR, Dixon DT, Rivera-Peraza CA, Gammage CJ, Mihalko WM, Harkess JW, Guyton JL, Crockarell JR, Ford MC. The AAHKS Clinical Research Award: Extended Postoperative Oral Tranexamic Acid in Total Knee Arthroplasty: A Randomized Controlled Pilot Study. J Arthroplasty. 2024 Sep;39(9 Suppl 2):S13-S17. doi: 10.1016/j.arth.2024.02.073. Epub 2024 Feb 29.
PubMed 38430972Keays SL, Mellifont DB, Keays AC, Stuelcken MC, Lovell DI, Sayers MGL. Long-term Return to Sports After Anterior Cruciate Ligament Injury: Reconstruction vs No Reconstruction-A Comparison of 2 Case Series. Am J Sports Med. 2022 Mar;50(4):912-921. doi: 10.1177/03635465211073152. Epub 2022 Feb 11.
PubMed 35148249Goldstein K, Jones C, Kay J, Shin J, de Sa D. Tranexamic Acid Administration in Arthroscopic Surgery Is a Safe Adjunct to Decrease Postoperative Pain and Swelling: A Systematic Review and Meta-analysis. Arthroscopy. 2022 Apr;38(4):1366-1377.e9. doi: 10.1016/j.arthro.2021.10.001. Epub 2021 Oct 14.
PubMed 34655767Felli L, Revello S, Burastero G, Gatto P, Carletti A, Formica M, Alessio-Mazzola M. Single Intravenous Administration of Tranexamic Acid in Anterior Cruciate Ligament Reconstruction to Reduce Postoperative Hemarthrosis and Increase Functional Outcomes in the Early Phase of Postoperative Rehabilitation: A Randomized Controlled Trial. Arthroscopy. 2019 Jan;35(1):149-157. doi: 10.1016/j.arthro.2018.07.050.
PubMed 30611343Cen L, Liu H, Li M, Zhang YF, Zhang HJ, Huang ZY. Intraoperative tranexamic acid reduces postoperative haemarthrosis and improves early functional outcomes in double-bundle anterior cruciate ligament reconstruction. J Orthop. 2024 Dec 10;65:51-56. doi: 10.1016/j.jor.2024.12.005. eCollection 2025 Jul.
PubMed 39801905
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07115056
- Acronym / sponsor ID
- Oral TXA After ACL-R
- Conditions
- ACL Injury, ACL Tears, ACL Surgery
- Keywords
- ACL, ACL Repair, ACL Reconstruction, TXA, tranexamic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty with study implement study related to staffing issue \& approvals.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Campbell ClinicUniversity, hospital or other
- Collaborators
- Duke University, University of Pittsburgh, Endeavor Health, University of Cincinnati, Washington University School of Medicine
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Group A (Placebo): Participants will receive 10 doses (30 capsules total) of microcrystalline cellulose (placebo), to be taken daily from postoperative day (POD) 1 through POD 10.
Group B (Oral TXA): Participants will receive 10 doses (30 capsules total) of oral TXA, dosed at 1.95 g per day (650 mg per capsule, 3 capsules daily) from POD 1 through POD 10.
All participants will receive standard intraoperative care, including 1 gram IV TXA prior to skin incision and an additional 1 gram IV TXA at surgical closure. Postoperative pain management will be administered per standard clinical practice and at the discretion of the treating surgical team.
Patient Population:
The study will enroll 100 patients aged 14 to 22 years undergoing isolated ACLR with a BTB autograft at Campbell Clinic Surgery Center and collaborating study sites.
Study Procedures:
Eligible patients will be identified via chart review and approached in clinic or via phone. Informed consent (and assent where applicable) will be obtained during a routine preoperative visit. Baseline data will be collected, including demographics and medical history. Participants will then be randomized and provided with study medication (oral TXA or placebo) to begin on POD 1.
Outcomes: 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.
Blinding and Allocation:
All capsules will be identical in appearance and packaging to maintain blinding. Randomization will be performed centrally and allocation concealed. Study staff, treating physicians, and patients will remain blinded until data analysis.
Safety Monitoring:
Participants will be monitored for adverse events throughout the study period. TXA is generally well tolerated but may pose thrombotic risk in susceptible individuals; exclusion criteria are designed to minimize this risk. The study team will report any serious adverse events (SAEs) to the IRB per institutional guidelines.
The study is powered to detect clinically meaningful differences in VAS scores, with a planned enrollment of 50 patients per group, allowing for a 20% loss to follow-up. This trial aims to clarify the role of extended postoperative oral TXA in reducing inflammation, pain, and bleeding in young ACLR patients, potentially offering a low-cost adjunct to current perioperative care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral TXA | Experimental | Drug: Tranexamic Acid (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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid (TXA)Oral tranexamic acid (TXA) is administered at a dose of 1.95 grams per day, divided into three 650 mg capsules taken once daily, starting on postoperative day (POD) 1 through POD 10 (10 total doses; 30 capsules) to the treatment group. | Drug | Oral TXA |
| PlaceboParticipants 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). | Drug | Placebo |
Primary outcome
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).
8 secondary outcomes
Knee Range of Motion
Time frame: Pre-op and 2-week, 6-week, 12-week, 6 months, 1-year post-op
Quadriceps Strength
Time frame: Pre-op and 2-week, 6-week, 12-week, 6 months, 1-year post-op
Isokinetic Strength
Time frame: 6 months, 9 months, 1-year post-op
Time to Straight Leg Raise
Time frame: Up to 1 year
Time to Return to Sport
Time frame: Up to 1 year
International Knee Documentation Committee Score
Time frame: Pre-op and 6 months, 1-year, 2-years post-op
Lysholm Knee Score
Time frame: Pre-op and 6 months, 1-year, 2-years post-op
Morphine Milligram Equivilants
Time frame: 2 weeks following surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 35099334Vermeijden HD, Yang XA, Rademakers MV, Kerkhoffs GMMJ, van der List JP, DiFelice GS. Early and Delayed Surgery for Isolated ACL and Multiligamentous Knee Injuries Have Equivalent Results: A Systematic Review and Meta-analysis. Am J Sports Med. 2023 Mar;51(4):1106-1116. doi: 10.1177/03635465211069356. Epub 2022 Jan 31.
- Background: PubMed 34027721Tan TK, Ng KT, Lim HJ, Radic R. Effect of tranexamic acid in arthroscopic anterior cruciate ligament repair: A systematic review and meta-analysis of randomised clinical trials. J Orthop Surg (Hong Kong). 2021 May-Aug;29(2):23094990211017352. doi: 10.1177/23094990211017352.
- Background: PubMed 39772756Romereim SM, Smykowski MR, Ball EK, Carey EG, Cuadra M, Williams A, Hickson K, Haim K, Sumith M, Yu Z, Jin G, Foureau D, Steuerwald N, Odum S, Fearing BV, Riboh JC. Immunophenotyping of Synovial Tissue in Adolescents Undergoing ACL Reconstruction: What Is the Role of Synovial Inflammation in Arthrofibrosis? Am J Sports Med. 2025 Feb;53(2):315-326. doi: 10.1177/03635465241305411. Epub 2025 Jan 7.
- Background: PubMed 38430972Kirwan MJ, Diltz ZR, Dixon DT, Rivera-Peraza CA, Gammage CJ, Mihalko WM, Harkess JW, Guyton JL, Crockarell JR, Ford MC. The AAHKS Clinical Research Award: Extended Postoperative Oral Tranexamic Acid in Total Knee Arthroplasty: A Randomized Controlled Pilot Study. J Arthroplasty. 2024 Sep;39(9 Suppl 2):S13-S17. doi: 10.1016/j.arth.2024.02.073. Epub 2024 Feb 29.
- Background: PubMed 35148249Keays SL, Mellifont DB, Keays AC, Stuelcken MC, Lovell DI, Sayers MGL. Long-term Return to Sports After Anterior Cruciate Ligament Injury: Reconstruction vs No Reconstruction-A Comparison of 2 Case Series. Am J Sports Med. 2022 Mar;50(4):912-921. doi: 10.1177/03635465211073152. Epub 2022 Feb 11.
- Background: PubMed 34655767Goldstein K, Jones C, Kay J, Shin J, de Sa D. Tranexamic Acid Administration in Arthroscopic Surgery Is a Safe Adjunct to Decrease Postoperative Pain and Swelling: A Systematic Review and Meta-analysis. Arthroscopy. 2022 Apr;38(4):1366-1377.e9. doi: 10.1016/j.arthro.2021.10.001. Epub 2021 Oct 14.
- Background: PubMed 30611343Felli L, Revello S, Burastero G, Gatto P, Carletti A, Formica M, Alessio-Mazzola M. Single Intravenous Administration of Tranexamic Acid in Anterior Cruciate Ligament Reconstruction to Reduce Postoperative Hemarthrosis and Increase Functional Outcomes in the Early Phase of Postoperative Rehabilitation: A Randomized Controlled Trial. Arthroscopy. 2019 Jan;35(1):149-157. doi: 10.1016/j.arthro.2018.07.050.
- Background: PubMed 39801905Cen L, Liu H, Li M, Zhang YF, Zhang HJ, Huang ZY. Intraoperative tranexamic acid reduces postoperative haemarthrosis and improves early functional outcomes in double-bundle anterior cruciate ligament reconstruction. J Orthop. 2024 Dec 10;65:51-56. doi: 10.1016/j.jor.2024.12.005. eCollection 2025 Jul.
- Individual participant dataSharing planned: No. IPD will not be shared due to concerns about participant privacy and confidentiality, limitations in resources to properly de-identify and manage data sharing, and institutional policies restricting data access. These measures are in place to ensure compliance with ethical standards and protect sensitive participant information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid (TXA) in people with ACL Injury and ACL Tears, run by Campbell Clinic at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Pre-op and 2 week, 6 week, 12 week, 6 months, 1 year, 2 year post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07115056, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.