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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-PR171647 | Other Grant/Funding Number | DoD |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Placebo | Placebo Comparator | 5-day course of placebo and intravenous saline during ACL reconstruction surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative MRI (qMRI) | To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves cartilage subsurface matrix structure assessed by qMRI UTE-T2* at 6 months after ACLR | 6 months post-ACLR |
| Quantitative MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine L Hoang, BS | Contact | 650-721-7612 | c1hoang@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Constance Chu, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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double blinded RCT
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| Placebos | Drug | 5-day course of oral placebo and intravenous saline during ACL reconstruction surgery |
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To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves cartilage subsurface matrix structure assessed by qMRI UTE-T2* at 2 years after ACLR
| 2 years post-ACLR |
| 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 2 years 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. | 2 years post-ACLR |