Reducing Hemarthrosis in ACL Reconstruction With BTB Autograft by the Administration of Intravenous TXA

Study Overview
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Brief Summary
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The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain.

Detailed Description
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The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain. Patients received the standard arthroscopic ACL reconstruction with a BTB autograft and were randomized to either receiving or not receiving two individual doses of TXA intra-operatively or receive. The goal of the study is to determine and evaluate the effect of intra-operative TXA on post-operative hemarthrosis, pain reduction, and opioid consumption.

Official Title
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Reducing Hemarthrosis in Anterior Cruciate Ligament Reconstruction With BTB Autograft by the Administration of Intravenous Tranexamic Acid: A Double-Blind Randomized Control Study

Conditions
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Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Drug: Tranexamic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -PATIENTS UNDERGOING AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT Exclusion Criteria: Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.) Younger than 18 years of age Any patient considered a vulnerable subject Have bleeding or clotting disorder Preoperative anticoagulation therapy Abnormal coagulation profile Renal disorder or insufficiency Sickle cell disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACL Reconstruction w/ BTB Autograft + IV TXA<br>Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients received two individual doses of intravenous TXA intra-operatively. | Drug: Tranexamic Acid<br>* One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.<br>|
| No Intervention: ACL Reconstruction w/ BTB Autograft, no IV TXA<br>Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients did not receive two individual doses of intravenous TXA intra-operatively. Only the consented surgery was performed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POST-OPERATIVE HEMARTHROSIS | Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration. | Post-operative week 1 | 
| POST-OPERATIVE Opioid Consumption | Each patient's opioid consumption was measured by morphine milligram equivalents (MME). | Days 1-7 | 
| POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS) | Pain severity, measured by the Visual Analog Scale (VAS): a scale of 1-10, with 1 being the least amount of pain and 10 being the most amount of pain. | Post-operative day 7 |